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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79162

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

Open FDA event record

Event summary

Timeline bucket
June 22, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Avid Medical, 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

23 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 23

AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09

Z-0780-2018
Recall number
Z-0780-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
50

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1205900, 1/1/2019; 1214034, 2/1/2019

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 2 of 23

AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12

Z-0781-2018
Recall number
Z-0781-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
200

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1205011 8/1/2019 1213805 10/1/2019

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 3 of 23

AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04

Z-0782-2018
Recall number
Z-0782-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
48

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1203562, 12/1/2017; 1206458, 1/1/2018

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 4 of 23

AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09

Z-0783-2018
Recall number
Z-0783-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
70

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1198747, 11/1/2018; 1199952, 10/1/2018; 1219974, 1/1/2019

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 5 of 23

AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06

Z-0784-2018
Recall number
Z-0784-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
354

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1193636 ,1/1/2019; 1198134, 10/1/2019

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 6 of 23

AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08

Z-0785-2018
Recall number
Z-0785-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
597

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1194408, 10/1/2018; 1204116, 10/1/2018; 1216669, 12/1/2018; 1216670, 11/1/2018

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 7 of 23

AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14

Z-0786-2018
Recall number
Z-0786-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
444

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1190449, 2/1/2019; 1210124, 6/1/2019; 1217082, 8/1/2019; 1219275, 3/1/2019; 1221265, 3/31/2019; 1222551, 7/1/2019

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 8 of 23

AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04

Z-0787-2018
Recall number
Z-0787-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
15

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1150308 ,1/1/2020

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 9 of 23

AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02

Z-0788-2018
Recall number
Z-0788-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
48

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1212610, 12/1/2017; 1218388, 8/1/2019

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 10 of 23

AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08

Z-0789-2018
Recall number
Z-0789-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
630

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1213947, 7/1/2019; 1216720, 10/1/2018; 1221271, 8/1/2017

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 11 of 23

AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07

Z-0790-2018
Recall number
Z-0790-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
160

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1191787, 7/1/2018; 1216674, 9/1/2019

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 12 of 23

AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02

Z-0791-2018
Recall number
Z-0791-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
24

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1197468, 8/1/2019; 1197469, 8/1/2019

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 13 of 23

AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02

Z-0792-2018
Recall number
Z-0792-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
12

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1197473, 6/1/2018; 1213733, 6/1/2018

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 14 of 23

AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04

Z-0793-2018
Recall number
Z-0793-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
120

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1207468, 9/1/2019; 1216677, 9/1/2019; 1221264, 9/20/2019; 1222553, 9/1/2019

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 15 of 23

AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01

Z-0794-2018
Recall number
Z-0794-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
44

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1210946, 8/1/2018; 1211091, 10/1/2018; 1213010, 8/1/2018

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 16 of 23

AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08

Z-0795-2018
Recall number
Z-0795-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
46

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1212598, 12/31/2018

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 17 of 23

AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06

Z-0796-2018
Recall number
Z-0796-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
90

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1198253, 9/1/2018; 1213945, 7/1/2018

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 18 of 23

AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016

Z-0797-2018
Recall number
Z-0797-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
8

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1211878, 7/1/2018

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 19 of 23

AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03

Z-0798-2018
Recall number
Z-0798-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
440

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1203380 ,8/1/2018; 1203381, 8/1/2018; 1203382, 12/1/2018; 1211709, 12/23/2018

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 20 of 23

AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03

Z-0799-2018
Recall number
Z-0799-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
52

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1203390, 9/1/2019; 1203391, 12/1/2017; 1218389, 10/1/2019; 1218390, 10/1/2019

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 21 of 23

AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02

Z-0800-2018
Recall number
Z-0800-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
24

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1203383, 9/1/2018; 1217833, 12/31/2018; 1218421, 12/1/2018

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 22 of 23

AVID TruCustom SPINE convenience kits, Item Code: LITT016-04

Z-0801-2018
Recall number
Z-0801-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
30

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1211095, 3/1/2018; 1216086, 3/1/2018

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

device · product 23 of 23

AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04

Z-0802-2018
Recall number
Z-0802-2018
Initiated
June 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
216

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

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

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

Code information

Lot, Expiration Date: 1189012 , 7/1/2019; 1213716, 9/1/2019; 1216726, 10/1/2019

Distribution pattern

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

Field note

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