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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91134

156 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 03, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DeRoyal Industries Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

156 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 156

DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15

Z-0560-2023
Recall number
Z-0560-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
78 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot 57589637, exp 6/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 2 of 156

DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15

Z-0561-2023
Recall number
Z-0561-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
828 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56185163 exp 2/1/2024; Lot 56390466 exp 2/1/2024; Lot 56616859 exp 2/1/2024; Lot 57390901 exp 1/1/2024; Lot 57466813 exp 10/1/2024; Lot 57589987 exp 6/1/2024; Lot 57674444 exp 6/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 3 of 156

DeRoyal EYE PACK, REF 89-4051.09

Z-0562-2023
Recall number
Z-0562-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
156 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56778647 exp 4/1/2023; Lot 57190263 exp 4/1/2023; Lot 57750460 exp 4/3/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 4 of 156

DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07

Z-0563-2023
Recall number
Z-0563-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
130 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56394918 exp 11/3/2024; Lot 56778591 exp 12/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 5 of 156

DeRoyal EYE TRAY, REF 89-4957.08

Z-0564-2023
Recall number
Z-0564-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
48 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 55646968 exp 6/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 6 of 156

DeRoyal PEDI ORTHO PACK, REF 89-5323.20

Z-0565-2023
Recall number
Z-0565-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
27 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56181816 exp 10/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 7 of 156

GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07

Z-0566-2023
Recall number
Z-0566-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56822290 exp 2/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 8 of 156

GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13

Z-0567-2023
Recall number
Z-0567-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
79 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56184443 exp 5/1/2023; Lot 56618408 exp 1/1/2023; Lot 57589531 exp 12/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 9 of 156

GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09

Z-0568-2023
Recall number
Z-0568-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
135 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56392226 exp 9/1/2023; Lot 56683525 exp 9/1/2023; Lot 57001506 exp 4/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 10 of 156

DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13

Z-0569-2023
Recall number
Z-0569-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
918 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56005273 exp 5/1/2024; Lot 56657845 exp 5/1/2024; Lot 57021523 exp 8/1/2024; Lot 57392244 exp 8/1/2024; Lot 57770575 exp 3/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 11 of 156

GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05

Z-0570-2023
Recall number
Z-0570-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
184 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56073866 exp 12/1/2023; Lot 56618070 exp 10/1/2024; Lot 57001434 exp 2/1/2025; Lot 57392105 exp 2/3/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 12 of 156

GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08

Z-0571-2023
Recall number
Z-0571-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
90 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56065591 exp 8/1/1024; Lot 56618230 exp 9/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 13 of 156

GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09

Z-0572-2023
Recall number
Z-0572-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
30 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 57709678 exp 10/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 14 of 156

DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09

Z-0573-2023
Recall number
Z-0573-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
144 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56391741 exp 1/1/2023; Lot 56617587 exp 2/1/2025; Lot 57391604 exp 1/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 15 of 156

DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07

Z-0574-2023
Recall number
Z-0574-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
3 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56391733 exp 3/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 16 of 156

DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09

Z-0575-2023
Recall number
Z-0575-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
42 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 57391516 exp 11/1/2024; Lot 57749549 exp 8/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 17 of 156

GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09

Z-0576-2023
Recall number
Z-0576-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
165 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56073840 exp 8/1/2022; Lot 56617675 exp 4/21/2023; Lot 57001291 exp 1/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 18 of 156

GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10

Z-0577-2023
Recall number
Z-0577-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
102 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57391655 exp 6/1/2023; Lot 57895706 exp 6/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 19 of 156

GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02

Z-0578-2023
Recall number
Z-0578-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
49 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 55441428 exp 7/1/2023; Lot 55966742 exp 10/1/2023; Lot 56777898 exp 12/1/2023; Lot 57391081 exp 2/1/2024; Lot 57748071 exp 2/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 20 of 156

DeRoyal SHOULDER PACK, REF 89-6830.13

Z-0579-2023
Recall number
Z-0579-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
876 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56184005 exp 11/1/2023; Lot 56254392 exp 10/1/2023; Lot 56777927 exp 1/1/2024; Lot 57391031 exp 2/1/2024; Lot 57684204 exp 5/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 21 of 156

DeRoyal CATARACT PACK CSM, REF 89-6863

Z-0580-2023
Recall number
Z-0580-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
1220 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 55807995 exp 1/1/2023; lot 56029890 exp ***; lot 57001098 exp ***; lot 57198118 exp ***; lot 56613261 exp ***

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 22 of 156

DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09

Z-0581-2023
Recall number
Z-0581-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
108 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56183862 exp 3/1/2025; Lot 56613244 exp 9/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 23 of 156

DeRoyal CANNULTED HIP PACK, REF 89-6977.10

Z-0582-2023
Recall number
Z-0582-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
36 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57198177 exp 4/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 24 of 156

DeRoyal BREAST TRAY, REF 89-7033.07

Z-0583-2023
Recall number
Z-0583-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
162 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56390335 exp 1/1/2024; Lot 57001021 exp 1/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 25 of 156

DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11

Z-0584-2023
Recall number
Z-0584-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
30 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57085711 exp 9/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 26 of 156

DeRoyal GU ROBOTIC PACK, REF 89-7063.12

Z-0585-2023
Recall number
Z-0585-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
192 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57387066 exp 9/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 27 of 156

DeRoyal CATARACT PACK, REF 89-7135.10

Z-0586-2023
Recall number
Z-0586-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
190 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 57312291 exp 12/1/2024; Lot 57500604 exp ***; Lot 56043472 exp ***; Lot 57894789 exp ***

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 28 of 156

DeRoyal TRANS CANAL PACK, REF 89-7157.12

Z-0587-2023
Recall number
Z-0587-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
156 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57029630 exp 8/1/2024; Lot 57387111 exp 6/1/2026; Lot 57894800 exp ***

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 29 of 156

DeRoyal LAPINECTOMY PACK, REF 89-7198.10

Z-0588-2023
Recall number
Z-0588-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
403 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56612971 exp 7/1/2026; Lot 56802580 exp 7/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 30 of 156

DeRoyal LAPINECTOMY PACK, REF 89-7198.11

Z-0589-2023
Recall number
Z-0589-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
715 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57091046 exp 7/1/2026; Lot 57224911 exp 5/1/2026; Lot 57387648 exp 8/1/2026; Lot 57748491 exp 10/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 31 of 156

DeRoyal BASIC NEURO PACK, REF 89-7258.10

Z-0590-2023
Recall number
Z-0590-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
108 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56777564 exp 5/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 32 of 156

DeRoyal BASIC NEURO PACK, REF 89-7258.12

Z-0591-2023
Recall number
Z-0591-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
96 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 57287655 exp 9/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 33 of 156

DeRoyal BASIC NEURO PACK, REF 89-7258.13

Z-0592-2023
Recall number
Z-0592-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
216 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 57748706 exp 11/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 34 of 156

DeRoyal VIT RD PACK 86ST, REF 89-7308.09

Z-0593-2023
Recall number
Z-0593-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
16 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57784627 exp 4/1/2025; Lot 57974922 exp ***

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 35 of 156

DeRoyal RETINAL PACK, REF 89-7336.07

Z-0594-2023
Recall number
Z-0594-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
64 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57000221 exp 9/1/2024; Lot 57413324 exp 12/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 36 of 156

DeRoyal CUSTOM NEURO PACK, REF 89-7353.17

Z-0595-2023
Recall number
Z-0595-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
36 kis

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57678322 exp 11/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 37 of 156

DeRoyal SPINAL FUSION PACK, REF 89-7515.12

Z-0596-2023
Recall number
Z-0596-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
27 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56254211 exp 6/1/2026; Lot 56841212 exp 9/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 38 of 156

DeRoyal SPINAL FUSION PACK, REF 89-7515.13

Z-0597-2023
Recall number
Z-0597-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
16 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 57197182 exp 2/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 39 of 156

DeRoyal SPINAL FUSION PACK, REF 89-7515.14

Z-0598-2023
Recall number
Z-0598-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
30 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 57746997 exp 12/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 40 of 156

DeRoyal BASIC NEURO PACK, REF 89-7523.15

Z-0599-2023
Recall number
Z-0599-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
288 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56611821 exp 8/1/2026; Lot 56881417 exp 9/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 41 of 156

DeRoyal BASIC NEURO PACK, REF 89-7523.16

Z-0600-2023
Recall number
Z-0600-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
304 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57227388 exp 5/1/2026; Lot 57466371 exp 11/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 42 of 156

DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09

Z-0601-2023
Recall number
Z-0601-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
264 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57197297 exp 3/1/1024; Lot 57746479 exp 5/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 43 of 156

DeRoyal ENDOVENOUS PACK, REF 89-7762.05

Z-0602-2023
Recall number
Z-0602-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
88 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 54880154 exp 12/1/2023; Lot 57186299 exp 10/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 44 of 156

DeRoyal EYE TRAY PGYBK, REF 89-7978.02

Z-0603-2023
Recall number
Z-0603-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
180 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56394686 exp 7/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 45 of 156

GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02

Z-0604-2023
Recall number
Z-0604-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
48 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56440662 exp 10/1/2024; Lot 56618491 exp 11/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 46 of 156

GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02

Z-0605-2023
Recall number
Z-0605-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
243 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56189375 exp 10/1/2024; Lot 56392381 exp 10/1/2024; Lot 56618504 exp 11/1/2024; Lot 57392455 exp 2/1/2025; Lot 5775963 exp 4/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 47 of 156

DeRoyal BASIC EYE PACK, REF 89-8337.08

Z-0606-2023
Recall number
Z-0606-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
45 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56386740 exp 8/1/2024; Lot 55970688 exp 08/01/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 48 of 156

DeRoyal BASIC EYE PACK, REF 89-8337.09

Z-0607-2023
Recall number
Z-0607-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
50 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57118632 exp 9/1/2024; Lot 57184285 exp 12/1/2024; Lot 57630628 exp 4/1/2025; Lot 57745978 exp 4/1/2025: Lot 57688413 exp 12/01/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 49 of 156

DeRoyal HEART PACK, REF 89-8351.11

Z-0608-2023
Recall number
Z-0608-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
240 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56189105 exp 9/1/2024; Lot 57005558 exp 9/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 50 of 156

DeRoyal HEART PACK, REF 89-8351.12

Z-0609-2023
Recall number
Z-0609-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
102 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 57367401 exp 3/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 51 of 156

DeRoyal HEART PACK, REF 89-8351.13

Z-0610-2023
Recall number
Z-0610-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
51 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57893436 exp 9/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 52 of 156

DeRoyal PODIATRY PACK, REF 89-8359.10

Z-0611-2023
Recall number
Z-0611-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
186 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56705544 exp 6/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 53 of 156

DeRoyal PODIATRY PACK, REF 89-8359.13

Z-0612-2023
Recall number
Z-0612-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
102 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57593741 exp 1/1/2027

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 54 of 156

DeRoyal SPINE PACK, REF 89-8361.08

Z-0613-2023
Recall number
Z-0613-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
243 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56189228 exp 4/1/2026; Lot 56614415 exp 2/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 55 of 156

DeRoyal SPINE PACK, REF 89-8361.09

Z-0614-2023
Recall number
Z-0614-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
144 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 57005620 exp 09/01/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 56 of 156

DeRoyal SPINE PACK, REF 89-8361.10

Z-0615-2023
Recall number
Z-0615-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
96 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 57745943 exp 12/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 57 of 156

DeRoyal CUSTOM NEURO PACK, REF 89-8392.09

Z-0616-2023
Recall number
Z-0616-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
12 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56614271 exp 4/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 58 of 156

DeRoyal CUSTOM NEURO PACK, REF 89-8392.10

Z-0617-2023
Recall number
Z-0617-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
12 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57745880 exp 12/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 59 of 156

DeRoyal BASIC PACK, REF 89-8633.07

Z-0618-2023
Recall number
Z-0618-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
130 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56188938 exp 6/1/2024; Lot 57022930 exp 6/1/2024; Lot 57825222 exp 6/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 60 of 156

GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01

Z-0619-2023
Recall number
Z-0619-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
76 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56618256 exp 3/1/2024; Lot 57005427 exp 11/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 61 of 156

GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02

Z-0620-2023
Recall number
Z-0620-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
16 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57745716 exp 10/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 62 of 156

DeRoyal PORT PACK PGYBK, REF 89-8748.05

Z-0621-2023
Recall number
Z-0621-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
240 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56250480 exp 9/1/2024; Lot 57391954 exp 10/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 63 of 156

GEO-MED BIOPSY TRAY, REF 89-8753.01

Z-0622-2023
Recall number
Z-0622-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
460 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56005548 exp 6/1/2023; Lot 57005363 exp 7/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 64 of 156

DeRoyal EYE PACK, REF 89-8756.03

Z-0623-2023
Recall number
Z-0623-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
72 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57344921 exp 11/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 65 of 156

DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04

Z-0624-2023
Recall number
Z-0624-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
100 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56781336 exp 11/1/2024; Lot 56882647 exp 10/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 66 of 156

DeRoyal ACDF PACK, REF 89-8779.03

Z-0625-2023
Recall number
Z-0625-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
45 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56188891 exp12/1/2023; Lot 56675066 exp 7/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 67 of 156

DeRoyal TLIF PACK, REF 89-8780.04

Z-0626-2023
Recall number
Z-0626-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
64 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56020431 exp 9/1/2023; Lot 56390757 exp 1/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 68 of 156

DeRoyal KIT TOTAL HIP, REF 89-8861.07

Z-0627-2023
Recall number
Z-0627-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
146 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 56390773 exp 6/1/2026; Lot 56617464 exp 6/1/2026; Lot 57085981 exp 10/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 69 of 156

DeRoyal KIT EXTREMITY PACK, REF 89-8869.09

Z-0628-2023
Recall number
Z-0628-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
75 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56390950 exp 6/1/2026; Lot 56837871 exp 9/1/2026; Lot 5718781 exp 10/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 70 of 156

DeRoyal KIT HEART B PACK, REF 89-9042.07

Z-0629-2023
Recall number
Z-0629-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
68 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56613762 exp 6/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 71 of 156

DeRoyal KIT HEART B PACK, REF 89-9042.08

Z-0630-2023
Recall number
Z-0630-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
68 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57388270 exp 8/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 72 of 156

DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08

Z-0631-2023
Recall number
Z-0631-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
180 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56066279 exp 6/1/2024; Lot 56631186 exp 6/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 73 of 156

DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09

Z-0632-2023
Recall number
Z-0632-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
90 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56973098 exp 6/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 74 of 156

DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10

Z-0633-2023
Recall number
Z-0633-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
100 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57757928 exp 9/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 75 of 156

DeRoyal TOTAL HIP PACK, REF 89-9113.06

Z-0634-2023
Recall number
Z-0634-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
16 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56042728 exp 5/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 76 of 156

DeRoyal TOTAL HIP PACK, REF 89-9113.07

Z-0635-2023
Recall number
Z-0635-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
8 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57460930 exp 2/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 77 of 156

DeRoyal BASIC EYE PACK, REF 89-9233.08

Z-0636-2023
Recall number
Z-0636-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
60 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57389942 exp 9/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 78 of 156

DeRoyal MAJOR ORTHO PACK, REF 89-9250.07

Z-0637-2023
Recall number
Z-0637-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
48 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56388551 exp 10/1/2024; Lot 56780333 exp 3/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 79 of 156

DeRoyal FOOT PACK, REF 89-9252.06

Z-0638-2023
Recall number
Z-0638-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
350 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56005476 exp 8/1/2024; Lot 56389449 exp 1/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 80 of 156

DeRoyal FOOT PACK, REF 89-9252.07

Z-0639-2023
Recall number
Z-0639-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
217 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57171601 exp 10/1/2024; Lot 57505843 exp 1/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 81 of 156

DeRoyal FOOT PACK, REF 89-9252.08

Z-0640-2023
Recall number
Z-0640-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
105 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57899862 exp 3/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 82 of 156

DeRoyal NEURO PACK, REF 89-9253.07

Z-0641-2023
Recall number
Z-0641-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
93 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56389334 exp 3/1/2025; Lot 56615629 exp 3/1/2025; Lot 57003940 exp 3/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 83 of 156

DeRoyal NEURO PACK, REF 89-9253.09

Z-0642-2023
Recall number
Z-0642-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
45 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57760211 exp 3/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 84 of 156

DeRoyal BIOPSY PACK, REF 89-9270.04

Z-0643-2023
Recall number
Z-0643-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
560 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56094211 exp 5/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 85 of 156

DeRoyal BIOPSY PACK, REF 89-9270.05

Z-0644-2023
Recall number
Z-0644-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
1200 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57119598 exp 8/1/2024; Lot 57754111 exp 10/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 86 of 156

DeRoyal TOTAL KNEE PACK, REF 89-9300.08

Z-0645-2023
Recall number
Z-0645-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
48 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57198935 exp 6/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 87 of 156

DeRoyal TOTAL HIP PACK, REF 89-9301.07

Z-0646-2023
Recall number
Z-0646-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
85 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56186932 exp 2/1/2025; Lot 57091222 exp 3/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 88 of 156

DeRoyal MYELOGRAM PACK, REF 89-9304.05

Z-0647-2023
Recall number
Z-0647-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
2280 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 55612944 exp 3/1/2026; Lot 56615881 exp 7/1/2026; Lot 56279557 exp 5/1/2026; Lot 57185350 exp7/1/2026; Lot 57591593 exp 1/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 89 of 156

DeRoyal MYELOGRAM PACK, REF 89-9304.06

Z-0648-2023
Recall number
Z-0648-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
480 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 57913388 exp 12/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 90 of 156

DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03

Z-0649-2023
Recall number
Z-0649-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
495 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56225516 exp 6/1/2024; Lot 56395460 exp 6/1/2024; Lot 56620751 exp 10/1/2024; Lot 56780958 exp 10/1/2024; Lot 57190141 exp 10/1/2024; Lot 57754751 exp 1/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 91 of 156

DeRoyal SHOULDER PACK, REF 89-9449.12

Z-0650-2023
Recall number
Z-0650-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
32 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56616218 exp 12/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 92 of 156

DeRoyal SHOULDER PACK, REF 89-9449.13

Z-0651-2023
Recall number
Z-0651-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
48 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57755295 exp 4/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 93 of 156

DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12

Z-0652-2023
Recall number
Z-0652-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
18 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 55969791 exp 5/1/2024; Lot 56755349 exp 6/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 94 of 156

DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13

Z-0653-2023
Recall number
Z-0653-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
6 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57199372 exp 6/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 95 of 156

DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14

Z-0654-2023
Recall number
Z-0654-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
18 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57754971 exp 1/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 96 of 156

DeRoyal SHOULDER KIT, REF 89-9497.08

Z-0655-2023
Recall number
Z-0655-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
14 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56580884 exp 12/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 97 of 156

DeRoyal SHOULDER KIT, REF 89-9497.10

Z-0656-2023
Recall number
Z-0656-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
28 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 576900006 exp 4/1/2025; Lot 57770532 exp 4/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 98 of 156

DeRoyal TOTAL HIP KIT, REF 89-9498.08

Z-0657-2023
Recall number
Z-0657-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
51 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56187960 exp 12/4/2024; Lot 57031051 exp 3/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 99 of 156

DeRoyal TOTAL HIP KIT, REF 89-9498.10

Z-0658-2023
Recall number
Z-0658-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
45 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57686947 exp 5/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 100 of 156

DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11

Z-0659-2023
Recall number
Z-0659-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
360 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56388673 exp 6/1/2026; Lot 56842522 exp 6/1/2026; Lot 57271485 exp 9/1/2026; Lot 57512154 exp 11/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 101 of 156

DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03

Z-0660-2023
Recall number
Z-0660-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
438 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 55862118 exp 6/1/2023; Lot 56394942 exp 6/1/2023; Lot 57004352 exp 9/1/2023; Lot 57686883 exp 10/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 102 of 156

DeRoyal UNIVERSAL PACK, REF 89-9558.03

Z-0661-2023
Recall number
Z-0661-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
75 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56187476 exp 12/1/2026; Lot 57190116 exp 4/1/2027

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 103 of 156

DeRoyal BIOPSY PACK, REF 89-9614.07

Z-0662-2023
Recall number
Z-0662-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
480 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56584885 exp 9/1/2024, Lot 57030745 exp 2/1/2025, Lot 57686461 exp 5/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 104 of 156

DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05

Z-0663-2023
Recall number
Z-0663-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
70 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 55968916 exp 7/1/2023; Lot 56620786 exp7/1/2023; Lot 56780667 exp 7/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 105 of 156

DeRoyal BIOPSY PACK, REF 89-9739.05

Z-0664-2023
Recall number
Z-0664-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
180 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56842514 exp 8/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 106 of 156

DeRoyal BIOPSY PACK, REF 89-9739.06

Z-0665-2023
Recall number
Z-0665-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
360 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57686568 exp 3/1/2027

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 107 of 156

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04

Z-0666-2023
Recall number
Z-0666-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
363 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56394580 exp 10/1/2024; Lot 56780181 exp12/1/2024; Lot 56822791 exp 11/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 108 of 156

DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06

Z-0667-2023
Recall number
Z-0667-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
63 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56186481 exp 11/1/2023; Lot 56431109 exp 1/1/2024; Lot 57189203 exp 6/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 109 of 156

DeRoyal FACIAL PACK PGYBK, REF 89-10007.03

Z-0668-2023
Recall number
Z-0668-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
35 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 55968449 exp 1/1/2024; Lot 56619751 exp 4/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 110 of 156

DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02

Z-0669-2023
Recall number
Z-0669-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57288181 exp 2/1/2024; Lot 56665247 exp 9/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 111 of 156

DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02

Z-0670-2023
Recall number
Z-0670-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56395179 exp 12/1/2023; Lot 56431133 exp 9/1/2023; Lot 57190554 exp 3/1/2024; Lot 5740754 exp 4/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 112 of 156

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02

Z-0671-2023
Recall number
Z-0671-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 55972430 exp 10/1/2022; Lot 56621455 exp 11/1/2023; Lot 57302780 exp 2/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 113 of 156

DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05

Z-0672-2023
Recall number
Z-0672-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
30 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56658012 exp 1/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 114 of 156

DeRoyal NEURO PACK, REF 89-10171.03

Z-0673-2023
Recall number
Z-0673-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
162 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 55790353 exp 4/1/2026; Lot 56387785 exp 5/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 115 of 156

DeRoyal NEURO PACK, REF 89-10171.05

Z-0674-2023
Recall number
Z-0674-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
60 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56927104 exp 5/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 116 of 156

DeRoyal NEURO PACK, REF 89-10171.06

Z-0675-2023
Recall number
Z-0675-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
159 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57184744 exp 5/1/2026; Lot 57685899 exp 3/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 117 of 156

DeRoyal CRANI PACK, REF 89-10202.03

Z-0676-2023
Recall number
Z-0676-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
16 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56705261 exp 6/1/2025

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 118 of 156

DeRoyal CRANI PACK, REF 89-10202.05

Z-0677-2023
Recall number
Z-0677-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
16 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57389117 exp 9/1/206

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 119 of 156

DeRoyal LAMINECTOMY PACK, REF 89-10209.02

Z-0678-2023
Recall number
Z-0678-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
12 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56388471 exp 6/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 120 of 156

DeRoyal LUMBAR FUSION PACK, REF 89-10211.05

Z-0679-2023
Recall number
Z-0679-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
51 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57714741 exp 8/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 121 of 156

DeRoyal PACEMAKER ICD PACK, REF 89-10216.03

Z-0680-2023
Recall number
Z-0680-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
90 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56705350 exp 6/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 122 of 156

DeRoyal PACEMAKER ICD PACK, REF 89-10216.06

Z-0681-2023
Recall number
Z-0681-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
75 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57898501 exp 3/1/2027

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 123 of 156

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03

Z-0682-2023
Recall number
Z-0682-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
56 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56465579 exp 7/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 124 of 156

DeRoyal CRANI PACK, REF 89-10242.02

Z-0683-2023
Recall number
Z-0683-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
6 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56388307 exp 8/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 125 of 156

DeRoyal CRANI PACK, REF 89-10242.04

Z-0684-2023
Recall number
Z-0684-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
8 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: Lot 5688188 exp 8/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 126 of 156

DeRoyal HAND PACK, REF 89-10314.02

Z-0685-2023
Recall number
Z-0685-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
18 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56615021 exp 6/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 127 of 156

DeRoyal HAND PACK, REF 89-10314.03

Z-0686-2023
Recall number
Z-0686-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
36 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57685848 exp 8/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 128 of 156

DeRoyal PAIN TRAY, REF 89-10464.02

Z-0687-2023
Recall number
Z-0687-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
1100 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 55971883 exp 7/1/2026; Lot 56477511 exp 7/1/2026; Lot 57002921 exp 9/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 129 of 156

DeRoyal PAIN TRAY, REF 89-10464.03

Z-0688-2023
Recall number
Z-0688-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
150 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57752107 exp 12/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 130 of 156

DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03

Z-0689-2023
Recall number
Z-0689-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
68 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56618811 exp 6/1/2023; Lot 56779017 exp 1/1/2024; Lot 57148495 exp 2/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 131 of 156

DeRoyal CNRV SPINAL PACK, REF 89-10532.03

Z-0690-2023
Recall number
Z-0690-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
69 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57188745 exp 3/1/2024; Lot 57393378 exp 5/1/2024; Lot 57663075 exp 05/01/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 132 of 156

DeRoyal CARDIAC LINEN PACK, REF 89-10543.02

Z-0691-2023
Recall number
Z-0691-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
204 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56336988 exp 11/1/2023; Lot 57188770 exp 8/1/2024; Lot 57393440 exp 5/1/2024; Lot 57644325 exp 7/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 133 of 156

DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01

Z-0692-2023
Recall number
Z-0692-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
1196 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56190288 exp 8/1/2023; Lot 56224943 exp 8/1/2023; Lot 56432718 exp 2/1/2023; Lot 56432726 exp 8/1/2023; Lot 56639065 exp 8/1/2023; Lot 56906961 exp 8/1/2023; Lot 57051271 exp 8/1/2023; Lot 57228161 exp 8/1/2023; Lot 57393491 exp 1/1/2024; Lot 57488967 exp 3/1/2024; Lot 57679350 exp 3/1/2024; Lot 57685371 exp 3/1/2024; Lot 57751551 exp 3/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 134 of 156

DeRoyal LUMBAR DISC PACK, REF 89-10590.02

Z-0693-2023
Recall number
Z-0693-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
6 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57022219 exp 3/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 135 of 156

DeRoyal LUMBAR DISC PACK, REF 89-10605.02

Z-0694-2023
Recall number
Z-0694-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
12 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57241041 exp 2/1/2024; Lot 57590494 exp 5/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 136 of 156

DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01

Z-0695-2023
Recall number
Z-0695-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
19 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 55970901 exp 11/1/2023; Lot 57591032 exp 1/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 137 of 156

DeRoyal GU PACK, REF 89-10665.02

Z-0696-2023
Recall number
Z-0696-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
75 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 55971461 exp 5/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 138 of 156

DeRoyal GU PACK, REF 89-10665.03

Z-0697-2023
Recall number
Z-0697-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
57 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57590304 exp 6/1/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 139 of 156

DeRoyal NEURO PACK, REF 89-10682.02

Z-0698-2023
Recall number
Z-0698-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
270 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56225794 exp 12/1/2023; Lot 56619110 exp 9/1/2023; Lot 57227898 exp 4/11/2024; Lot 57927051 exp 5/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 140 of 156

DeRoyal LAMI/CRANI PACK, REF 89-10787.01

Z-0699-2023
Recall number
Z-0699-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
36 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56219159 exp 4/1/2026; Lot 56593562 exp 4/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 141 of 156

GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01

Z-0700-2023
Recall number
Z-0700-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
170 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56618893 exp 6/1/2024; Lot 57002242 exp 6/1/2024; Lot 57187646 exp 6/1/20

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 142 of 156

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02

Z-0701-2023
Recall number
Z-0701-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
32 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56865450 exp 1/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 143 of 156

DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01

Z-0702-2023
Recall number
Z-0702-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
180 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57187574 exp 4/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 144 of 156

DeRoyal PACEMAKER ICD PACK, REF 89-10902.01

Z-0703-2023
Recall number
Z-0703-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
60 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57805969 exp 11/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 145 of 156

DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02

Z-0704-2023
Recall number
Z-0704-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
10 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 57749071 exp 2/1/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 146 of 156

DeRoyal BIOPSY PACKPACK, REF 89-9756.05

Z-0705-2023
Recall number
Z-0705-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: Lot 56842493 exp 8/1/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 147 of 156

DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02

Z-0706-2023
Recall number
Z-0706-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
117 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: 56296761 exp 10/01/2023; 56717318 exp 11/01/2023; 57136671 exp 11/01/2023; 57225673 exp 11/01/2023; 57225817 exp 02-01-2024; 57455920 exp 02-01-2024; 57646161 exp 02-01-2024; 57889699 exp 02-01-2024; 58003853 exp 02-01-2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 148 of 156

DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02

Z-0707-2023
Recall number
Z-0707-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
336 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: 56169083 exp 12/01/2023; 56357092 exp 12/01/2023; 56481018 exp 12/01/2023; 56538205 exp 09/01/2023; 56873265 exp 09/01/2023; 56895966 exp 09/01/2023; 56942611 exp 03/01/2024; 57088584 exp 03/01/2024; 57088592 exp 03/01/2024; 57180516 exp 03/01/2024; 57270562 exp 03/01/2024; 57313163 exp 03/01/2024; 57313171 exp 03/01/2024; 57492608 exp 03/01/2024; 57646152 exp 03/01/2024; 57681329 exp 03/01/2024; 57717598 exp 03/01/2024; 57788708 exp 03/01/2024; 57889681 exp 03/01/2024; 57928563 exp 03/01/2024; 57960070 exp 03/01/2024; 58003845 exp 04/01/2024; 58032523 exp 04/01/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 149 of 156

DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02

Z-0708-2023
Recall number
Z-0708-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
72 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: 56573668 exp 45170; 56670564 exp 45170; 56847198 exp 45170; 57564851 exp 45323; 57889672 exp 45323; 58032515 exp 45323;

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 150 of 156

GEO-MED CATARACT PACK, REF 89-5790.08

Z-0709-2023
Recall number
Z-0709-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
834 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: 55966890 exp 02/01/2023; 56020131 exp 03/01/2023; 56184435 exp 02/01/2023; 56618387 exp 06/01/2023; 57001493 exp 06/01/2023; 57227821 exp 09/01/2023; 57466709 exp 09/01/2023; 57589522 exp 09/01/2023; 57749750 exp 12/01/2023; 5786389 ezp 12/01/2023

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 151 of 156

DeRoyal CATARACT PACK, REF 89-8650.10

Z-0710-2023
Recall number
Z-0710-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
440 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: 55749537 exp 08/01/2023;

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 152 of 156

DeRoyal CATARACT PACK, REF 89-8859.08

Z-0711-2023
Recall number
Z-0711-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
530 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: 57755800 exp 12/01/2026;

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 153 of 156

DeRoyal CATARACT PACK, REF 89-9241.03

Z-0712-2023
Recall number
Z-0712-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
368 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: 55990451 exp 08/01/2024; 56615717 exp 08/01/2024

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 154 of 156

DeRoyal CATARACT PACK, REF 89-9241.04

Z-0713-2023
Recall number
Z-0713-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
552 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: 57198898 exp 12/01/2024; 57686605 exp 04/01/2025; 57754049 exp

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 155 of 156

DeRoyal CATARACT PACK, REF 89-10040.01

Z-0714-2023
Recall number
Z-0714-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
108 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Lot Numbers: 56125881 exp 05/01/2026; 56618926 exp 05/01/2026; 57485029 exp 11/01/2026

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

device · product 156 of 156

DeRoyal CATARACT PACK, REF 89-10086.05

Z-0715-2023
Recall number
Z-0715-2023
Initiated
November 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
520 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information

Lot Numbers: 57003552 exp 09/01/2024; 57467226 exp 12/01/2024; 55748075 exp *; 56250244 exp *; 57899344 exp *; 57913353 exp *

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Field note

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