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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95415

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

Open FDA event record

Event summary

Timeline bucket
September 04, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

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

33 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 33

Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit

Z-0148-2025
Recall number
Z-0148-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
30 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40193489435246 (each), 10193489435245 (case), Lot Numbers: 23LBM753, 23KBD877

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 2 of 33

Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit

Z-0149-2025
Recall number
Z-0149-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
90 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40653160307816 (each), 10653160307815 (case), Lot Numbers: 23LBK889

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 3 of 33

Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY

Z-0150-2025
Recall number
Z-0150-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
168 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) UDI/DI 40653160270929 (each), 10653160270928 (case), Lot Numbers: 23LBO858; b) UDI/DI 40653160284346 (each), 10653160284345 (case), Lot Numbers: 23LBL653

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 4 of 33

Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit

Z-0151-2025
Recall number
Z-0151-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
30 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40653160995877 (each), 10653160995876 (case), Lot Numbers: 24ABD184

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 5 of 33

Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kit

Z-0152-2025
Recall number
Z-0152-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
15 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40193489967273 (each), 10193489967272 (case), , Lot Numbers: 23KBQ236

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 6 of 33

Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A

Z-0153-2025
Recall number
Z-0153-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
320 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) DYNJ80370A, UDI/DI 40195327388547 (each), 10195327388546 (case), Lot Numbers: 23LBM330; b) DYNJRA1854A, UDI/DI 40195327117062 (each), 10195327117061 (case), Lot Numbers: 23LBJ089

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 7 of 33

Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B

Z-0154-2025
Recall number
Z-0154-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
312 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) DYNJ36320A, UDI/DI 40889942245230 (each), 10889942245239 (case), Lot Numbers: 24ABC836; b) DYNJ41876B, UDI/DI 40193489563086 (each), 10193489563085 (case), Lot Numbers: 23LBM850

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 8 of 33

Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) LFT HRT CATH RADIAL ACCESS-LF, REF DYNJ47667C; g) IR ARM PACK, REF DYNJ50712D; h) IR PACK, REF DYNJ67324; i) PL. CATHETERISME CARDIAQUE, REF HCT093J

Z-0155-2025
Recall number
Z-0155-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
1460 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) REF DYNDH1609: UDI/DI 40193489844802 (each), 10193489844801 (case), Lot Numbers: 23LBO852; b) REF DYNJ19010I: UDI/DI 40888277858627 (each), 10888277858626 (case), Lot Numbers: 23LBK443; c) REF DYNJ29207: UDI/DI 40080196015413 (each), 10080196015412 (case), Lot Numbers: 23LBL962; d) REF DYNJ43661C: UDI/DI 40195327104353 (each), 10195327104351 (case), Lot Numbers: 23LBU931; e) REF DYNJ46746C: UDI/DI 40195327040162 (each), 10195327040161 (case), Lot Numbers: 23LBK374; f) REF DYNJ47667C: UDI/DI 40195327040179 (each), 10195327040178 (case), Lot Numbers: 23LBL629; g) REF DYNJ50712D: UDI/DI 40195327267927 (each), 10195327267926 (case), Lot Numbers: 23KBE846; h) REF DYNJ67324: UDI/DI 40193489395625 (each), 10193489395624 (case), Lot Numbers: 23LBL780; i) REF HCT093J: UDI/DI 40884389905679 (each), 10884389905678 (case), Lot Numbers: 23LBG513

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 9 of 33

Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ32727A; a) VASCULAR PACK-LF, REF DYNJ32915B; a) SUAREZ AVR/MVR PACK, REF DYNJ35884C; a) VALVE ACCESSORY PACK, REF DYNJ36241K; a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B; a) EP PACK, REF DYNJ40488; a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G; a) PACEMAKER TEGH-LF, REF DYNJ46745A; a) VEIN AND LASER PACK, REF DYNJ49874; a) DR NACKMAN VEIN PACK, REF DYNJ56235; a) NEUROVASCULAR PACK, REF DYNJ66718A; a) VEIN TRAY, REF DYNJ69012C; a) LOOP RECORDER-LF, REF DYNJ69196; a) U BAR DRAPE, REF DYNJ80064; a) ENDO, REF DYNJ903814B; a) CARDIAC PROCEDURE, REF DYNJ908126; a) CARDIAC PROCEDURE, REF DYNJ908126; a) VASCULAR EXTREMITY PACK, REF SYNJ10322A; a) VASCULAR EXTREMITY, REF SYNJ910026A

Z-0156-2025
Recall number
Z-0156-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
2631 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) REF CDS983202I, UDI/DI 40195327164677 (each), 10195327164676 (case), Lot Numbers: 23LBI662; b) REF DYNDC2486A, UDI/DI 40889942648055 (each). 10889942648054 (case), Lot Numbers: 23LBM830; c) REF DYNJ01201L, UDI/DI 40888277744807 (each), 10888277744806 (case), Lot Numbers: 23LBP126; d) REF DYNJ0537343G, UDI/DI 40193489517072 (each), 10193489517071 (case), Lot Numbers: 23LBP442; e) REF DYNJ32727A, UDI/DI 40888277036346 (each), 10888277036345 (case), Lot Numbers: 24ABB296; f) REF DYNJ32915B, UDI/DI 40195327486427 (each), 10195327486426 (case), Lot Numbers: 23LBK382; g) REF DYNJ35884C, UDI/DI 40195327547609 (each), 10195327547608 (case), Lot Numbers: 24ABF463; h) REF DYNJ36241K, UDI/DI 40195327555949 (each), 10195327555948 (case), Lot Numbers: 23LBL339; i) REF DYNJ38084B, UDI/DI 40889942670841 (each), 10889942670840 (case), Lot Numbers: 23LBR317; j) REF DYNJ40488, UDI/DI 40884389861685 (each), 10884389861684 (case), Lot Numbers: 23LBL628; k) REF DYNJ41925G, UDI/DI 40193489677349 (each), 10193489677348 (case), Lot Numbers: 24ABA421; l) REF DYNJ46745A, UDI/DI 40889942279297 (each), 10889942279296 (case), Lot Numbers: 23KBB860; m) REF DYNJ49874, UDI/DI 40888277890603 (each), 10888277890602 (case), Lot Numbers: 23LBL699; n) REF DYNJ56235, UDI/DI 40889942621553 (each), 10889942621552 (case), Lot Numbers: 23EBD843A; o) REF DYNJ66718A, UDI/DI 40193489916332 (each), 10193489916331 (case), Lot Numbers: 24ABN915; p) REF DYNJ69012C, UDI/DI 40195327515943 (each), 10195327515942 (case), Lot Numbers: 23LBQ949; q) REF DYNJ69196, UDI/DI 40193489906234 (each), 10193489906233 (case), Lot Numbers: 23LBR843; r) REF DYNJ80064, UDI/DI 40195327009251 (each), 10195327009250 (case), Lot Numbers: 23LBP174; s) REF DYNJ903814B, UDI/DI 40195327333769 (each), 10195327333768 (case), Lot Numbers: 23LBS865; t) REF DYNJ908126, UDI/DI 40193489980111 (each), 10193489980110 (case), Lot Numbers: 24BBA256; u) REF DYNJ908126, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers: 24ABN040; v) REF SYNJ10322A, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers: 24ABD377; w) REF SYNJ910026A, UDI/DI 40193489374491 (each), 10193489374490 (case), Lot Numbers: 24ABV352

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 10 of 33

Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PACK-LF, REF DYNJ28487; g) PICC PACK-LF, REF DYNJ28487H; h) CENTRAL LINE PACK, REF DYNJ30087C; i) CENTRAL LINE ADULT PACK, REF DYNJ35352; j) PICC PACK, REF DYNJ52255; k) PICC PROCEDURE PACK, REF DYNJ59067A; l) PICC PROCEDURE PACK, REF DYNJ59067A; m) DR SIRAGUSA VEIN PACK, REF DYNJ61247A; n) PICC TEAM PACK, REF DYNJ64542A; o) PICC LINE INSERTION PACK, REF DYNJ65519; p) CVL INSERTION KIT II PGYBK, REF DYNJ68112; q) CVL INSERTION KIT II PGYBK, REF DYNJ68112; r) PICC PACK, REF DYNJ69088A; s) PICC INSERTION TRAY, REF DYNJ80031; t) ENDOVENOUS ABLATION PACK, REF DYNJ80489A; u) CVR ENDOVENOUS PACK, REF DYNJ80643; v) RADIAL ARTERY PACK, REF DYNJ83938;

Z-0157-2025
Recall number
Z-0157-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
5238 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) REF CVI4730A, UDI/DI 40195327562039 (each), 10195327562038 (case), Lot Numbers: 24ABK903; b) REF CVI4730A, UDI/DI 40195327562039 (each), 10195327562038 (case), Lot Numbers: 23LBN351; c) REF DYNJ20803D, UDI/DI 40889942553885 (each), 10889942553884 (case), Lot Numbers: 24ABE939; d) REF DYNJ28368, UDI/DI 40080196200161 (each), 10080196200160 (case), Lot Numbers: 24ABD995; e) REF DYNJ28368, UDI/DI UDI/DI 40080196200161 (each), 10080196200160 (case), Lot Numbers: 23KBE939; f) REF DYNJ28487, UDI/DI 40080196227021 (each), 10080196227020 (case), Lot Numbers: 24ABI626; g) REF DYNJ28487H, UDI/DI40080196227021 (each), 10080196227020 (case), Lot Numbers: 24ABI626; h) REF DYNJ30087C, UDI/DI 40889942754145 (each), 10889942754144 (case), Lot Numbers: 23JBS113; i) REF DYNJ35352, UDI/DI 40884389433080 (each), 10884389433089 (case), Lot Numbers: 23LBN154; j) REF DYNJ52255, UDI/DI 40889942253709 (each), 10889942253708 (case), Lot Numbers: 24ABC063; k) REF DYNJ59067A, UDI/DI 40195327421282 (each), 10195327421281 (case), Lot Numbers: 24ABC903; l) REF DYNJ59067A, UDI/DI 40195327421282 (each), 10195327421281 (case), Lot Numbers: 23LBM072; m) REF DYNJ61247A, UDI/DI 40195327492862 (each), 10195327492861 (case), Lot Numbers: 23LBN198; n) REF DYNJ64542A, UDI/DI 40193489293723 (each), 0193489293722 (case), Lot Numbers: 23LBN027; o) REF DYNJ65519, UDI/DI 40193489283939 (each), 10193489283938 (case), Lot Numbers: 24ABE345; p) REF DYNJ68112, UDI/DI 40193489498906 (each), 10193489498905 (case), Lot Numbers: 24ABH428; q) REF DYNJ68112, UDI/DI 40193489498906 (each), 10193489498905 (case), Lot Numbers: 23LBT018; r) REF DYNJ69088A, UDI/DI 40193489975247 (each), 10193489975246 (case), Lot Numbers: 23LBP745; s) REF DYNJ80031, UDI/DI 40195327007745 (each), 10195327007744 (case), Lot Numbers: 23LBN003; t) REF DYNJ80489A, UDI/DI 40195327582723 (each), 10195327582722 (case), Lot Numbers: 23LBP033; u) REF DYNJ80643, UDI/DI 40195327055791 (each), 10195327055790 (case), Lot Numbers: 23KBK131; v) REF DYNJ83938, UDI/DI 40195327317233 (each), 101953273172329 (case), Lot Numbers: 24ABG864

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 11 of 33

Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF DYNJ63165B; g) BIOPSY TRAY FOAKS, REF DYNJ63575A; h) CUSTOM SOFT TISSUE PACK, REF DYNJ66347A; i) KWIK PACK, REF DYNJ67926B; j) ESI TRAY, REF DYNJ68261B; k) LARGE BIOPSY PACK NTX, REF DYNJ68393A; l) LOOP KIT, REF DYNJ84129

Z-0158-2025
Recall number
Z-0158-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
2,426 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) REF DYNJ17534L, UDI/DI 40195327258253 (each), 10195327258252 (case), Lot Numbers: 23KBF936; b) REF DYNJ43076A, UDI/DI 40195327080625 (each), 10195327080624 (case), Lot Numbers: 23LBI584; c) REF DYNJ49404C, UDI/DI 40195327395453 (each), 10195327395452 (case), Lot Numbers: 23LBP833; d) REF DYNJ52666C, UDI/DI 40193489452144 (each), 10193489452143 (case), Lot Numbers: 23LBN740; e) REF DYNJ61130B, UDI/DI 40195327054589 (each), 10195327054588 (case), Lot Numbers: 23LBP401; f) REF DYNJ63165B, UDI/DI 40193489461580 (each), 10193489461589 (case), Lot Numbers: 23KBD517; g) REF DYNJ63575A, UDI/DI 40193489429337 (each), 10193489429336 (case), Lot Numbers: 23LBR787; h) REF DYNJ66347A, UDI/DI 40193489884716 (each), 10193489884715 (case), Lot Numbers: 24ABA444; i) REF DYNJ67926B, UDI/DI 40195327519514 (each), 10195327519513 (case), Lot Numbers: 23LBL347; j) REF DYNJ68261B, UDI/DI 40195327513369 (each), 10195327513368 (case), Lot Numbers: 24ABA492; k) REF DYNJ68393A, UDI/DI 40193489939997 (each), 10193489939996 (case), Lot Numbers: 23LBL431; l) REF DYNJ84129, UDI/DI 40195327334544 (each), 10195327334543 (case), Lot Numbers: 23KBB926

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 12 of 33

Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit

Z-0159-2025
Recall number
Z-0159-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
165 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40195327120420 (each), 10195327120429 (case), Lot Numbers: 24ABF266

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 13 of 33

Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40836F; 7) ENT PACK, REF DYNJ44249J; 8) TONSIL PACK, REF DYNJ44349L; 9) TONSIL PACK, REF DYNJ44349M; 10) NASAL PACK, REF DYNJ53200C; 11) TONSIL & ADENOIDS PACK, REF DYNJ53270C; 12) FTMC MYRINGOTOMY PACK-LF, REF DYNJ54610A; 13) HEAD AND NECK PACK, REF DYNJ55255C; 14) ENT T&A PACK, REF DYNJ58979; 15) EENT PACK, REF DYNJ62927; 16) ENT, REF DYNJ63190A; 17) D L B PACK, REF DYNJ66274A; 18) ASC T&A, REF DYNJ67109B; 19) TONSIL T AND A PACK SHD, REF DYNJ68417C; 20) T A PACK, REF DYNJ80227B; 21) TONSIL AND ADENOID PACK, REF DYNJ80559A; 22) T AND A PACK UMMC KIT, REF DYNJ81880; 23) T/A ENDO PACK, REF DYNJ83158; 24) JVL - MODULE T A PK, REF DYNJ84083; 25) T&A, REF DYNJ900289J; 26) T&A, REF DYNJ900289J; 27) T & A, REF DYNJ902626G; 28) LARYNGOSCOPY BRONCH-LF, REF DYNJ903264A; 29) T&A, REF DYNJ903428J; 30) T&A, REF DYNJ903428J; 31) PEDI ENT - OAKBEND, REF DYNJ905769; 32) T & A, REF DYNJ907056C; 33) ASC FARRELL T&A, REF DYNJ908132; 34) CHS ENT PACK, REF DYNJCH500

Z-0160-2025
Recall number
Z-0160-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
2740 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

1) REF CDS982091I, UDI/DI 40193489741644 (each), 10193489741643 (case), Lot Numbers: 24BBA623; 2) REF CDS984492B, UDI/DI 40193489637183 (each), 10193489637182 (case), Lot Numbers: 24ABB114; 3) REF DYNJ0798129I, UDI/DI 40195327226511 (each), 10195327226510 (case), Lot Numbers: 23KBB859; 4) REF DYNJ30591I, UDI/DI 40193489962841 (each), 10193489962840 (case), Lot Numbers: 24ABD228; 5) REF DYNJ37171A, UDI/DI 40884389750620 (each), 10884389750629 (case), Lot Numbers: 23KBD998; 6) REF DYNJ40836F, UDI/DI 40195327059539 (each), 10195327059538 (case), Lot Numbers: 23LBQ627; 7) REF DYNJ44249J, UDI/DI 40195327483020 (each), 10195327483029 (case), Lot Numbers: 23KBE536; 8) REF DYNJ44349L, UDI/DI 40195327394531 (each), 10195327394530 (case), Lot Numbers: 23KBD353; 9) REF DYNJ44349M, UDI/DI 40195327564378 (each), 10195327564377 (case), Lot Numbers: 24ABA446; 10) REF DYNJ53200C, UDI/DI 40193489779371 (each), 10193489779370 (case), Lot Numbers: 23KBC298; 11) REF DYNJ53270C, UDI/DI 40193489812566 (each), 10193489812565 (case), Lot Numbers: 23KBA462; 12) REF DYNJ54610A, UDI/DI 40195327456451 (each), 10195327456450 (case), Lot Numbers: 24ABD026; 13) REF DYNJ55255C, UDI/DI 40195327493753 (each), 10195327493752 (case), Lot Numbers: 23KBD956; 14) REF DYNJ58979, UDI/DI 40889942914938 (each), 10889942914937 (case), Lot Numbers: 24ABD861; 15) REF DYNJ62927, UDI/DI 40193489700245 (each), 10193489700244 (case), Lot Numbers: 23LBQ806; 16) REF DYNJ63190A, UDI/DI 40193489304603 (each), 10193489304602 (case), Lot Numbers: 23LBN122; 17) REF DYNJ66274A, UDI/DI 40195327151981 (each), 10195327151980 (case), Lot Numbers: 24ABB272; 18) REF DYNJ67109B, UDI/DI 40195327207084 (each), 10195327207083 (case), Lot Numbers: 24ABC426; 19) REF DYNJ68417C, UDI/DI 40195327341634 (each), 10195327341633 (case), Lot Numbers: 23KBC605; 20) REF DYNJ80227B, UDI/DI 40195327220144 (each), 10195327220143 (case), Lot Numbers: 24ABC423; 21) REF DYNJ80559A, UDI/DI 40195327512522 (each), 10195327512521 (case), Lot Numbers: 23LBP334; 22) REF DYNJ81880, UDI/DI 40195327153671 (each), 10195327153670 (case), Lot Numbers: 24ABE284; 23) REF DYNJ83158, UDI/DI 40195327236886 (each), 10195327236885 (case), Lot Numbers: 23LBU511; 24) REF DYNJ84083, UDI/DI 40195327332236 (each), 10195327332235 (case), Lot Numbers: 23LBL823; 25) REF DYNJ900289J, UDI/DI 40195327554034 (each), 10195327554033 (case), Lot Numbers: 24ABS131; 26) REF DYNJ900289J, UDI/DI 40195327554034 (each), 10195327554033 (case), Lot Numbers: 24ABE249; 27) REF DYNJ902626G, UDI/DI 40195327214334 (each), 10195327214333 (case), Lot Numbers: 24ABU280; 28) REF DYNJ903264A, UDI/DI 40889942632566 (each), 10889942632565 (case), Lot Numbers: 23LBF682; 29) REF DYNJ903428J, UDI/DI 40195327575060 (each), 10195327575069 (case), Lot Numbers: 24CBI692; 30) REF DYNJ903428J, UDI/DI 40195327575060 (each), 10195327575069 (case), Lot Numbers: 24ABS337; 31) REF DYNJ905769, UDI/DI 40193489507998 (each), 10193489507997 (case), Lot Numbers: 24ABS137; 32) REF DYNJ907056C, UDI/DI 40195327276875 (each), 10195327276874 (case), Lot Numbers: 24ABA207; 33) REF DYNJ908132, UDI/DI 40193489981521 (each), 10193489981520 (case), Lot Numbers: 24CBA800; 34) REF DYNJCH500, UDI/DI 40884389900421 (each), 10884389900420 (case), Lot Numbers: 23LBP611

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 14 of 33

Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7) MINOR PACK, REF DYNJ42132A; 8) RECTAL PRONE PACK, REF DYNJ43380A; 9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716; 10) CYSTO PACK, REF DYNJ47821F; 11) CYSTO PACK, REF DYNJ48978C; 12) CYSTO PACK, REF DYNJ50428C; 13) MID HUDSON CYSTO PACK, REF DYNJ53418B; 14) CYSTO PACK-LF, REF DYNJ55479D; 15) CYSTO PACK, REF DYNJ58445A; 16) MINOR PACK, REF DYNJ58566B; 17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431; 18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A; 19) FLEXIBLE CYS PACK, REF DYNJ62111C; 20) CYSTO PACK, REF DYNJ65830A; 21) MAIN & ODS CYSTO PACK, REF DYNJ66821A; 22) PROCEDURE CYSTO PACK, REF DYNJ68883; 23) CYSTO PACK, REF DYNJ69729; 24) MINOR SURGERY PACK, REF DYNJ80004; 25) LAPAROSCOPY PACK, REF DYNJ80763; 26) LAPAROSCOPY PACK, REF DYNJ80763; 27) CYSTO PACK, REF DYNJ82626; 28) MINOR PACK, REF DYNJ83155; 29) SY CYSTO, REF DYNJ900583M; 30) CYSTO, REF DYNJ905569B; 31) CYSTO, REF DYNJ907541A; 32) SET UP PACK-LF, REF LLSCASET01; 33) MAJOR PACK, REF SYNJ910011B

Z-0161-2025
Recall number
Z-0161-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
5972 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

1) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 24ABW238; 2) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 23KBU714; 3) REF DYNJ25834B, UDI/DI 40193489849555 (each) 10193489849554 (case), Lot Numbers: 24ABG332; 4) REF DYNJ35569C, UDI/DI 40195327498253 (each) 10195327498252 (case), Lot Numbers: 23LBL736; 5) REF DYNJ40724D, UDI/DI 40195327420773 (each) 10195327420772 (case), Lot Numbers: 24ABG713; 6) REF DYNJ41105C, UDI/DI 40193489969659 (each) 10193489969658 (case), Lot Numbers: 24ABA628; 7) REF DYNJ42132A, UDI/DI 40195327385270 (each) 10195327385279 (case), Lot Numbers: 23LBS108; 8) REF DYNJ43380A, UDI/DI 40888277265913 (each) 10888277265912 (case), Lot Numbers: 23KBD028; 9) REF DYNJ46716, UDI/DI 40888277597069 (each) 10888277597068 (case), Lot Numbers: 23LBM976; 10) REF DYNJ47821F, UDI/DI 40193489956796 (each) 10193489956795 (case), Lot Numbers: 24ABC507; 11) REF DYNJ48978C, UDI/DI 40195327325948 (each) 10195327325947 (case), Lot Numbers: 23LBP883; 12) REF DYNJ50428C, UDI/DI 40195327504039 (each) 10195327504038 (case), Lot Numbers: 23LBN301; 13) REF DYNJ53418B, UDI/DI 40195327372270 (each) 10195327372279 (case), Lot Numbers: 23LBO773; 14) REF DYNJ55479D, UDI/DI 40195327416769 (each) 10195327416768 (case), Lot Numbers: 23LBL444; 15) REF DYNJ58445A, UDI/DI 40195327585953 (each) 10195327585952 (case), Lot Numbers: 23LBU911; 16) REF DYNJ58566B, UDI/DI 40195327243228 (each) 10195327243227 (case), Lot Numbers: 23KBC919; 17) REF DYNJ59431, UDI/DI 40888277741257 (each) 10888277741256 (case), Lot Numbers: 24ABG210; 18) REF DYNJ60077A, UDI/DI 40193489862905 (each) 10193489862904 (case), Lot Numbers: 23LBO542; 19) REF DYNJ62111C, UDI/DI 40195327312146 (each) 10195327312145 (case), Lot Numbers: 23LBP204; 20) REF DYNJ65830A, UDI/DI 40195327588732 (each) 10195327588731 (case), Lot Numbers: 23LBR366; 21) REF DYNJ66821A, UDI/DI 40193489974929 (each) 10193489974928 (case), Lot Numbers: 23KBQ852; 22) REF DYNJ68883, UDI/DI 40193489848329 (each) 10193489848328 (case), Lot Numbers: 23KBC527; 23) REF DYNJ69729, UDI/DI 40193489973267 (each) 10193489973266 (case), Lot Numbers: 24ABD664; 24) REF DYNJ80004, UDI/DI 40195327005192 (each) 10195327005191 (case), Lot Numbers: 23LBP094; 25) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 24ABG464; 26) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 23LBU050; 27) REF DYNJ82626, UDI/DI 40195327199488 (each) 10195327199487 (case), Lot Numbers: 24ABN216; 28) REF DYNJ83155, UDI/DI 40195327236855 (each) 10195327236854 (case), Lot Numbers: 23LBV474; 29) REF DYNJ900583M, UDI/DI 40195327061853 (each) 10195327061852 (case), Lot Numbers: 24ABU214; 30) REF DYNJ905569B, UDI/DI 40193489995672 (each) 10193489995671 (case), Lot Numbers: 24ABJ966; 31) REF DYNJ907541A, UDI/DI 40195327054268 (each) 10195327054267 (case), Lot Numbers: 23KBT202; 32) REF LLSCASET01, UDI/DI 40080196120681 (each) 10080196120680 (case), Lot Numbers: 23LBM079; 33) REF SYNJ910011B, UDI/DI 40195327246809 (each) 10195327246808 (case), Lot Numbers: 24ABS212

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 15 of 33

Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit

Z-0162-2025
Recall number
Z-0162-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
1180 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40653160992944 (each), 10653160992943 (case) , Lot Numbers: 23LBO846

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 16 of 33

Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit

Z-0163-2025
Recall number
Z-0163-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
90 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40195327429752 (each), 10195327429751 (case), Lot Numbers: 23LBL499

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 17 of 33

Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; e) TRAY FOL LATX UM COUD 18FR MF, REF DYND150218CS; f) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; g) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; h) TRAY FOLEY SIL 16FR 10ML W/UM, REF DYND150816; i) TRAY FOL SIL UM COUD 16FR MF, REF DYND150816CS; j) TRAY FOL SIL 16FR 10ML W/UM MF, REF DYND150816S; k) TRAY FOL SIL UM COUD 18FR MF, REF DYND150818CS; l) TRAY FOL SIL 18FR 10ML W/UM MF, REF DYND150818S

Z-0164-2025
Recall number
Z-0164-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
8830 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) REF DYND150200S, UDI/DI 40195327387885 (each), 10195327387884 (case), Lot Numbers: 23LBK182; b) REF DYND150216CS, UDI/DI 40195327388059 (each), 10195327388058 (case), Lot Numbers: 23LBK183; c) REF DYND150216S, UDI/DI 40195327387366 (each), 10195327387365 (case), Lot Numbers: 23LBO854; d) REF DYND150216S, UDI/DI 40195327387366 (each), 10195327387365 (case), Lot Numbers: 23LBL067; e) REF DYND150218CS, UDI/DI 40195327388066 (each), 10195327388065 (case), Lot Numbers: 23LBL068; f) REF DYND150218S, UDI/DI 40195327388004 (each), 10195327388003 (case), Lot Numbers: 23LBP852; g) REF DYND150218S, UDI/DI 40195327388004 (each), 10195327388003 (case), Lot Numbers: 23KBK538; h) REF DYND150816, UDI/DI 40195327043064 (each), 10195327043063 (case), Lot Numbers: 23KBE406; i) REF DYND150816CS, UDI/DI 40195327149919 (each), 10195327149918 (case), Lot Numbers: 23KBU812; j) REF DYND150816S, UDI/DI 40195327149711 (each), 10195327149710 (case), Lot Numbers: 24ABA832; k) REF DYND150818CS, UDI/DI 40195327149926 (each), 10195327149925 (case), Lot Numbers: 23LBH302; l) REF DYND150818S, UDI/DI 40195327149889 (each), 10195327149888 (case), Lot Numbers: 23KBF923

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 18 of 33

Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF DYNJ53205B; g) PLASTIC PACK, REF DYNJ57895; h) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803; i) BREAST PACK, REF DYNJ64376; j) CSTM PK SURGISTART MAINE PLAST, REF DYNJ66619A; k) PLASTIC PACK, REF DYNJ68030; l) CUSTOM PLASTIC PACK, REF DYNJ68062; m) PLASTIC LIMB SJHC-LF, REF DYNJ84997

Z-0165-2025
Recall number
Z-0165-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
1048 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) DYNJ42735A, UDI/DI 40888277226433 (each), 10888277226432 (case), Lot Numbers: 23LBP975; b) DYNJ43457, UDI/DI 40888277055309 (each), 10888277055308 (case), Lot Numbers: 23LBS052; c) DYNJ46717A, UDI/DI 40193489650014 (each), 10193489650013 (case), Lot Numbers: 24ABF270; d) DYNJ46717A, UDI/DI 40193489650014 (each), 10193489650013 (case), Lot Numbers: 23LBO013; e) DYNJ53205B, UDI/DI 40193489424851 (each), 10193489424850 (case), Lot Numbers: 24ABC805; f) DYNJ53205B, UDI/DI 40193489424851 (each), 10193489424850 (case), Lot Numbers: 23LBN742; g) DYNJ57895, UDI/DI 40889942790372 (each), 10889942790371 (case), Lot Numbers: 23KBF265; h) DYNJ62803, UDI/DI 40193489688994 (each), 10193489688993 (case), Lot Numbers: 23LBN303; i) DYNJ64376, UDI/DI 40193489807845 (each), 10193489807844 (case), Lot Numbers: 24ABD094; j) DYNJ66619A, UDI/DI 40195327427840 (each), 10195327427849 (case), Lot Numbers: 23LBU414; k) DYNJ68030, UDI/DI 40193489469289 (each), 10193489469288 (case), Lot Numbers: 23LBL117; l) DYNJ68062, UDI/DI 40193489474580 (each), 10193489474589 (case), Lot Numbers: 24ABC304; m) DYNJ84997, UDI/DI 40195327444212 (each), 10195327444211 (case), Lot Numbers: 23LBK468

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 19 of 33

Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML MF, REF DYND150814TS; 7) TRAY FOL TEMP UM 14FR 10ML MF, REF DYND150814TS; 8) CUSTOM KIT, REF DYNDA2060; 9) CHEST TRAY PACK, REF DYNDA2203; 10) PK LESION CSTM, REF DYNDA2914; 11) BRONCH ESOPHAGOSCOPY PACK, REF DYNDH1765; 12) SOFT TISSUE PACK, REF DYNJ00017M; 13) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I; 14) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I; 15) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I; 16) MINOR PACK-LF, REF DYNJ0410060S; 17) CYSTO I TRAY, REF DYNJ14063D; 18) CYSTO I TRAY, REF DYNJ14063D; 19) CYSTO PACK, REF DYNJ17310D; 20) DENTAL PK-LF, REF DYNJ21241D; 21) CYSTO PACK-LF, REF DYNJ25042I; 22) BASIC PACK-LF, REF DYNJ25450I; 23) BASIC PACK-LF, REF DYNJ25450J; 24) OPS T&A PACK, REF DYNJ26876F; 25) BASIC PACK, REF DYNJ31835G; 26) DENTAL PACK, REF DYNJ32991C; 27) MEDVET PROCEDURE PACK, REF DYNJ34226C; 28) MEDVET PROCEDURE PACK, REF DYNJ34226C; 29) CYSTO, REF DYNJ34527B; 30) UNIVERSAL PACK, REF DYNJ35593D; 31) T&A PACK, REF DYNJ36434A; 32) ENSEMBLE PROCEDURE MINEURE-LF, REF DYNJ38085C; 33) TYMPANOMASTOID PACK, REF DYNJ39342C; 34) OB DELIVERY PACK, REF DYNJ39377C; 35) PK,ENT-T&A, REF DYNJ39548A; 36) PACEMAKER SET UP PACK-LF, REF DYNJ40010B; 37) GENERAL OVERBED PACK, REF DYNJ40045B; 38) GENERAL OVERBED PACK, REF DYNJ40045B; 39) MAJOR OPHTHALMIC, REF DYNJ40317; 40) ENSEMBLE ACCOUCHEMENT-LF, REF DYNJ40933A; 41) ORL TYMPANO PACK BJC-LF, REF DYNJ41674A; 42) TURP PACK BWH-LF, REF DYNJ41706C; 43) TURP PACK BWH-LF, REF DYNJ41706C; 44) CYSTOSCOPY PACK BWH-LF, REF DYNJ41709B; 45) ORAL SURGERY PACK WRO-LF, REF DYNJ41862C; 46) MAJOR CYSTO PACK WRO-LF, REF DYNJ41871B; 47) BASIC SET UP TRAY-LF, REF DYNJ42142A; 48) CHEST TUBE, REF DYNJ42491; 49) BASIC PACK-LF, REF DYNJ43400C; 50) ENT PACK, REF DYNJ43538B; 51) MGASC MINOR PK-22025183, REF DYNJ44818D; 52) GEN SURG - MINOR-LF, REF DYNJ45731A; 53) STERILE FIELD, REF DYNJ46227B; 54) STERILE FIELD, REF DYNJ46227B; 55) BASIC PACK, REF DYNJ47823C; 56) MINOR PACK, REF DYNJ49825C; 57) CYSTO PACK, REF DYNJ50073B; 58) CYSTO PACK, REF DYNJ50073B; 59) 7497 VAT SURGICAL KIT, REF DYNJ50320B; 60) ENSEMBLE CYSTOSCOPIE-LF, REF DYNJ50946A; 61) ENT PACK, REF DYNJ51360; 62) PK-GEN-BASIC, REF DYNJ52220A; 63) MINOR PACK, REF DYNJ52782C; 64) LEG ROLL KIT, REF DYNJ53020; 65) CYSTO PACK-LF, REF DYNJ53204A; 66) TREATMENT ROOM TRAY-LF, REF DYNJ53268; 67) BASIC SET UP PK, REF DYNJ53509B; 68) T AND A PACK, REF DYNJ54087A; 69) TUR PACK, REF DYNJ54483A; 70) FTMC LOCAL PACK-LF, REF DYNJ54607B; 71) TONSIL PACK, REF DYNJ54765C; 72) SPINAL CORD STIMULATION, REF DYNJ57294; 73) T&A PACK, REF DYNJ57810; 74) PROCEDURE PACK, REF DYNJ58538; 75) ENSEMBLE MAIN/POIGNET, REF DYNJ59375; 76) MINOR PACK, REF DYNJ59621A; 77) CYSTO, REF DYNJ60307A; 78) MEDVET PROCEDURE PACK, REF DYNJ60368B; 79) DR. HUNT PACK, REF DYNJ61218; 80) CYSTO PACK, REF DYNJ61506A; 81) SLCH DIGITAL XRAY PACK, REF DYNJ61664A; 82) MHPB CONVERSION PACK, REF DYNJ62027A; 83) SMALL PROCEDURE PACK, REF DYNJ62231; 84) DENTAL PACK, REF DYNJ62619A; 85) BASIC PACK-LF, REF DYNJ63522A; 86) BASIC PACK, REF DYNJ64865; 87) INFERTILITY PACK, REF DYNJ65720; 88) SETUP PACK, REF DYNJ67675A; 89) TLPO PACK, REF DYNJ68312; 90) SURGERY PACK, REF DYNJ68458; 91) KF PACK 2.0, REF DYNJ69619; 92) SURGERY PACK, REF DYNJ69692; 93) DR GREEN PACK, REF DYNJ80043; 94) DRAPE PACK II, REF DYNJ80154B; 95) UNIVERSAL PACK, REF DYNJ80178A; 96) GENERAL SURGERY PACK, REF DYNJ80194; 97) SUPPLEMENT MIPS PK, REF DYNJ80244C; 98) UNIVERSAL PACK, REF DYNJ80401A; 99) UNIVERSAL PACK, REF DYNJ80401A; 100) LITHOTOMY PACK, REF DYNJ80765; 101) PKY LITHOTOMY PACK, REF DYNJ81656A; 102) SOFT TISSUE PACK, REF DYNJ82029; 103) MAJOR SURGI

Z-0166-2025
Recall number
Z-0166-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
22,327 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 · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

1) REF 00-400616J, UDI/DI 40193489592246 (each), 10193489592245 (case), Lot Numbers: 24ABI725; 2) REF 3706WHST, UDI/DI 40193489445702 (each), 10193489445701 (case), Lot Numbers: 24ABG100; 3) REF CDS980427J, UDI/DI 40889942823575 (each), 10889942823574 (case), Lot Numbers: 24DBG751; 4) REF CDS984603, UDI/DI 40884389853789 (each), 10884389853788 (case), Lot Numbers: 24BBB784; 5) REF CHT745, UDI/DI 40653160263655 (each), 10653160263654 (case), Lot Numbers: 23LBM800; 6) REF DYND150814TS, UDI/DI 40195327149704 (each), 10195327149703 (case), Lot Numbers: 23KBD258; 7) REF DYND150814TS, UDI/DI 40195327149704 (each), 10195327149703 (case), Lot Numbers: 23KBA940; 8) REF DYNDA2060, UDI/DI 40889942697336 (each), 10889942697335 (case), Lot Numbers: 24ABN606; 9) REF DYNDA2203, UDI/DI 40889942813774 (each), 10889942813773 (case), Lot Numbers: 24ABD615; 10) REF DYNDA2914, UDI/DI 40195327092802 (each), 10195327092801 (case), Lot Numbers: 23LBL366; 11) REF DYNDH1765, UDI/DI 40195327205769 (each), 10195327205768 (case), Lot Numbers: 24ABG092; 12) REF DYNJ00017M, UDI/DI 40195327492039 (each), 10195327492038 (case), Lot Numbers: 24ABD093; 13) REF DYNJ0259819I, UDI/DI 40193489972901 (each), 10193489972900 (case), Lot Numbers: 24ABB267; 14) REF DYNJ0259819I, UDI/DI 40193489972901 (each), 10193489972900 (case), Lot Numbers: 23KBO771; 15) REF DYNJ0259819I, UDI/DI 40193489972901 (each), 10193489972900 (case), Lot Numbers: 23JBS007; 16) REF DYNJ0410060S, UDI/DI 40195327440894 (each), 10195327440893 (case), Lot Numbers: 23LBR879; 17) REF DYNJ14063D, UDI/DI 40884389873619 (each), 10884389873618 (case), Lot Numbers: 24ABF481; 18) REF DYNJ14063D, UDI/DI 40884389873619 (each), 10884389873618 (case), Lot Numbers: 23LBN035; 19) REF DYNJ17310D, UDI/DI 40193489775403 (each), 10193489775402 (case), Lot Numbers: 23LBK791; 20) REF DYNJ21241D, UDI/DI 40884389838878 (each), 10884389838877 (case), Lot Numbers: 23LBL798; 21) REF DYNJ25042I, UDI/DI 40889942802426 (each), 10889942802425 (case), Lot Numbers: 23LBS919; 22) REF DYNJ25450I, UDI/DI 40889942136200 (each), 10889942136209 (case), Lot Numbers: 23KBE169; 23) REF DYNJ25450J, UDI/DI 40195327573677 (each), 10195327573676 (case), Lot Numbers: 24ABG313; 24) REF DYNJ26876F, UDI/DI 40884389608150 (each), 10884389608159 (case), Lot Numbers: 24ABC156; 25) REF DYNJ31835G, UDI/DI 40193489705509 (each), 10193489705508 (case), Lot Numbers: 24ABD033; 26) REF DYNJ32991C, UDI/DI 40889942913658 (each), 10889942913657 (case), Lot Numbers: 23LBL686; 27) REF DYNJ34226C, UDI/DI 40888277762306 (each), 10888277762305 (case), Lot Numbers: 23LBL752; 28) REF DYNJ34226C, UDI/DI 40888277762306 (each), 10888277762305 (case), Lot Numbers: 23KBE103; 29) REF DYNJ34527B, UDI/DI 40193489668255 (each), 10193489668254 (case), Lot Numbers: 24ABE279; 30) REF DYNJ35593D, UDI/DI 40193489928182 (each), 10193489928181 (case), Lot Numbers: 23LBI864; 31) REF DYNJ36434A, UDI/DI 40888277057730 (each), 10888277057739 (case), Lot Numbers: 24ABB540; 32) REF DYNJ38085C, UDI/DI 40889942671169 (each), 10889942671168 (case), Lot Numbers: 23LBR333; 33) REF DYNJ39342C, UDI/DI 40889942353423 (each), 10889942353422 (case), Lot Numbers: 23LBR035; 34) REF DYNJ39377C, UDI/DI 40888277760135 (each), 10888277760134 (case), Lot Numbers: 23KBF280; 35) REF DYNJ39548A, UDI/DI 40884389909141 (each), 10884389909140 (case), Lot Numbers: 24ABB335; 36) REF DYNJ40010B, UDI/DI 40889942908678 (each), 10889942908677 (case), Lot Numbers: 23KBA116; 37) REF DYNJ40045B, UDI/DI 40889942683919 (each), 10889942683918 (case), Lot Numbers: 23LBM922; 38) REF DYNJ40045B, UDI/DI 40889942683919 (each), 10889942683918 (case), Lot Numbers: 23KBF156; 39) REF DYNJ40317, UDI/DI 40884389850474 (each), 10884389850473 (case), Lot Numbers: 24ABC781; 40) REF DYNJ40933A, UDI/DI 40193489845359 (each), 10193489845358 (case), Lot Numbers: 23LBM102; 41) REF DYNJ41674A, UDI/DI 40889942860129 (each), 10889942860128 (case), Lot Numbers: 24ABB568; 42) REF DYNJ41706C, UDI/DI 40193489662796 (each), 10193489662795 (case), Lot Numbers: 24ABG266; 43) REF DYNJ41706C, UDI/DI 40193489662796 (each), 10193489662795 (case), Lot Numbers: 23LBR757; 44) REF DYNJ41709B, UDI/DI 40888277284440 (each), 10888277284449 (case), Lot Numbers: 23LBK417; 45) REF DYNJ41862C, UDI/DI 40193489676922 (each), 10193489676921 (case), Lot Numbers: 23KBF154; 46) REF DYNJ41871B, UDI/DI 40193489662017 (each), 10193489662016 (case), Lot Numbers: 23KBN364; 47) REF DYNJ42142A, UDI/DI 40888277831187 (each), 10888277831186 (case), Lot Numbers: 24ABA117; 48) REF DYNJ42491, UDI/DI 40884389925035 (each), 10884389925034 (case), Lot Numbers: 24ABB278; 49) REF DYNJ43400C, UDI/DI 40193489447744 (each), 10193489447743 (case), Lot Numbers: 23LBU893; 50) REF DYNJ43538B, UDI/DI 40888277584137 (each), 10888277584136 (case), Lot Numbers: 23LBV457; 51) REF DYNJ44818D, UDI/DI 40193489984133 (each), 10193489984132 (case), Lot Numbers: 23KBT511; 52) REF DYNJ45731A, UDI/DI 40889942637721 (each), 10889942637720 (case), Lot Numbers: 24ABD039; 53) REF DYNJ46227B, UDI/DI 40193489854436 (each), 10193489854435 (case), Lot Numbers: 24ABM200; 54) REF DYNJ46227B, UDI/DI 40193489854436 (each), 10193489854435 (case), Lot Numbers: 24ABA452; 55) REF DYNJ47823C, UDI/DI 40193489956789 (each), 10193489956788 (case), Lot Numbers: 24ABB573; 56) REF DYNJ49825C, UDI/DI 40193489506397 (each), 10193489506396 (case), Lot Numbers: 23KBB473; 57) REF DYNJ50073B, UDI/DI 40193489208055 (each), 10193489208054 (case), Lot Numbers: 23LBU510; 58) REF DYNJ50073B, UDI/DI 40193489208055 (each), 10193489208054 (case), Lot Numbers: 23KBD577; 59) REF DYNJ50320B, UDI/DI 40193489349697 (each), 10193489349696 (case), Lot Numbers: 24ABA672; 60) REF DYNJ50946A, UDI/DI 40889942671237 (each), 10889942671236 (case), Lot Numbers: 24ABG215; 61) REF DYNJ51360, UDI/DI 40889942158639 (each), 10889942158638 (case), Lot Numbers: 24ABB279; 62) REF DYNJ52220A, UDI/DI 40889942581963 (each), 10889942581962 (case), Lot Numbers: 23LBP897; 63) REF DYNJ52782C, UDI/DI 40193489568654 (each), 10193489568653 (case), Lot Numbers: 23LBP253; 64) REF DYNJ53020, UDI/DI 40889942361220 (each), 10889942361229 (case), Lot Numbers: 24ABE280; 65) REF DYNJ53204A, UDI/DI 40889942394662 (each), 10889942394661 (case), Lot Numbers: 24ABG188; 66) REF DYNJ53268, UDI/DI 40889942394938 (each), 10889942394937 (case), Lot Numbers: 23KBD061; 67) REF DYNJ53509B, UDI/DI 40195327467945 (each), 10195327467944 (case), Lot Numbers: 24ABA330; 68) REF DYNJ54087A, UDI/DI 40193489528788 (each), 10193489528787 (case), Lot Numbers: 23LBL773; 69) REF DYNJ54483A, UDI/DI 40889942620990 (each), 10889942620999 (case), Lot Numbers: 24ABG233; 70) REF DYNJ54607B, UDI/DI 40195327456680 (each), 10195327456689 (case), Lot Numbers: 23LBV155; 71) REF DYNJ54765C, UDI/DI 40195327550012 (each), 10195327550011 (case), Lot Numbers: 24ABG401; 72) REF DYNJ57294, UDI/DI 40889942737407 (each), 10889942737406 (case), Lot Numbers: 24ABG021; 73) REF DYNJ57810, UDI/DI 40889942779117 (each), 10889942779116 (case), Lot Numbers: 23LBM155; 74) REF DYNJ58538, UDI/DI 40889942866404 (each), 10889942866403 (case), Lot Numbers: 23KBI131; 75) REF DYNJ59375, UDI/DI 40888277736116 (each), 10888277736115 (case), Lot Numbers: 23LBM752; 76) REF DYNJ59621A, UDI/DI 40193489685375 (each), 10193489685374 (case), Lot Numbers: 23KBC997; 77) REF DYNJ60307A, UDI/DI 40193489691703 (each), 10193489691702 (case), Lot Numbers: 24ABE301; 78) REF DYNJ60368B, UDI/DI 40195327168613 (each), 10195327168612 (case), Lot Numbers: 23KBC801; 79) REF DYNJ61218, UDI/DI 40193489548885 (each), 10193489548884 (case), Lot Numbers: 23LBL020; 80) REF DYNJ61506A, UDI/DI 40193489783255 (each), 10193489783254 (case), Lot Numbers: 24ABC133; 81) REF DYNJ61664A, UDI/DI 40193489470261 (each), 10193489470260 (case), Lot Numbers: 23KBC463; 82) REF DYNJ62027A, UDI/DI 40193489626842 (each), 10193489626841 (case), Lot Numbers: 24ABG214; 83) REF DYNJ62231, UDI/DI 40193489637220 (each), 10193489637229 (case), Lot Numbers: 23KBD005; 84) REF DYNJ62619A, UDI/DI 40193489358286 (each), 10193489358285 (case), Lot Numbers: 24ABE270; 85) REF DYNJ63522A, UDI/DI 40195327428199 (each), 10195327428198 (case), Lot Numbers: 23LBU500; 86) REF DYNJ64865, UDI/DI 40193489224918 (each), 10193489224917 (case), Lot Numbers: 23KBD860; 87) REF DYNJ65720, UDI/DI 40193489285179 (each), 10193489285178 (case), Lot Numbers: 23LBP965; 88) REF DYNJ67675A, UDI/DI 40195327366231 (each), 10195327366230 (case), Lot Numbers: 23LBS280; 89) REF DYNJ68312, UDI/DI 40193489821940 (each), 10193489821949 (case), Lot Numbers: 24ABG206; 90) REF DYNJ68458, UDI/DI 40193489463195 (each), 10193489463194 (case), Lot Numbers: 23LBN052; 91) REF DYNJ69619, UDI/DI 40193489959445 (each), 10193489959444 (case), Lot Numbers: 23KBE167; 92) REF DYNJ69692, UDI/DI 40193489970211 (each), 10193489970210 (case), Lot Numbers: 23KBF303; 93) REF DYNJ80043, UDI/DI 40195327010769 (each), 10195327010768 (case), Lot Numbers: 24ABC517; 94) REF DYNJ80154B, UDI/DI 40195327218912 (each), 10195327218911 (case), Lot Numbers: 23KBR662; 95) REF DYNJ80178A, UDI/DI 40195327296842 (each), 10195327296841 (case), Lot Numbers: 24ABC430; 96) REF DYNJ80194, UDI/DI 40195327014187 (each), 10195327014186 (case), Lot Numbers: 23LBM855; 97) REF DYNJ80244C, UDI/DI 40195327542024 (each), 10195327542023 (case), Lot Numbers: 23LBP429; 98) REF DYNJ80401A, UDI/DI 40195327239573 (each), 10195327239572 (case), Lot Numbers: 23LBP471; 99) REF DYNJ80401A, UDI/DI 40195327239573 (each), 10195327239572 (case), Lot Numbers: 23KBE914; 100) REF DYNJ80765, UDI/DI 40195327074969 (each), 10195327074968 (case), Lot Numbers: 23KBB377; 101) REF DYNJ81656A, UDI/DI 40195327498499 (each), 10195327498498 (case), Lot Numbers: 23KBD944; 102) REF DYNJ82029, UDI/DI 40195327162109 (each), 10195327162108 (case), Lot Numbers: 23KBC835; 103) REF DYNJ82427, UDI/DI 40195327194582 (each), 10195327194581 (case), Lot Numbers: 23LBV375; 104) REF DYNJ82500B, UDI/DI 40195327373086 (each), 10195327373085 (case), Lot Numbers: 23LBO296; 105) REF DYNJ82500B, UDI/DI 40195327373086 (each), 10195327373085 (case), Lot Numbers: 23LBM804; 106) REF DYNJ82700D, UDI/DI 40195327561254 (each), 10195327561253 (case), Lot Numbers: 23LBM966; 107) REF DYNJ82715, UDI/DI 40195327204304 (each), 10195327204303 (case), Lot Numbers: 24ABC127; 108) REF DYNJ82850A, UDI/DI 40195327244812 (each), 10195327244811 (case), Lot Numbers: 24ABD666; 109) REF DYNJ82873, UDI/DI 40195327213153 (each), 10195327213152 (case), Lot Numbers: 23LBL690; 110) REF DYNJ83203, UDI/DI 40195327244553 (each), 10195327244552 (case), Lot Numbers: 23LBP730; 111) REF DYNJ83250, UDI/DI 40195327248612 (each), 10195327248611 (case), Lot Numbers: 23KBF282; 112) REF DYNJ83330, UDI/DI 40195327262151 (each), 10195327262150 (case), Lot Numbers: 23LBP731; 113) REF DYNJ83596, UDI/DI 40195327284443 (each), 10195327284442 (case), Lot Numbers: 24ABD078; 114) REF DYNJ84440, UDI/DI 40195327365128 (each), 10195327365127 (case), Lot Numbers: 23LBV275; 115) REF DYNJ85234, UDI/DI 40195327481392 (each), 10195327481391 (case), Lot Numbers: 23LBL820; 116) REF DYNJ85234, UDI/DI 40195327481392 (each), 10195327481391 (case), Lot Numbers: 23KBF800; 117) REF DYNJ85628, UDI/DI 40195327526697 (each), 10195327526696 (case), Lot Numbers: 23LBV274; 118) REF DYNJ85709, UDI/DI 40195327537600 (each), 10195327537609 (case), Lot Numbers: 24ABK573; 119) REF DYNJ900120F, UDI/DI 40193489851343 (each), 10193489851342 (case), Lot Numbers: 24ABS299; 120) REF DYNJ907048A, UDI/DI 40193489370288 (each), 10193489370287 (case), Lot Numbers: 24BBC990; 121) REF DYNJ909048, UDI/DI 40195327257775 (each), 10195327257774 (case), Lot Numbers: 24ABC721; 122) REF DYNJ909048, UDI/DI 40195327257775 (each), 10195327257774 (case), Lot Numbers: 23KBP667; 123) REF DYNJ909288A, UDI/DI 40195327488278 (each), 10195327488277 (case), Lot Numbers: 24CBA276; 124) REF DYNJ909288A, UDI/DI 40195327488278 (each), 10195327488277 (case), Lot Numbers: 24ABW976; 125) REF DYNJCH914, UDI/DI 40193489448284 (each), 10193489448283 (case), Lot Numbers: 23LBP583; 126) REF DYNJCH914, UDI/DI 40193489448284 (each), 10193489448283 (case), Lot Numbers: 23KBB451; 127) REF DYNJHTLD01, UDI/DI 40888277079077 (each), 10888277079076 (case), Lot Numbers: 23LBV200; 128) REF DYNJHTLD01, UDI/DI 40888277079077 (each), 10888277079076 (case), Lot Numbers: 23KBD588; 129) REF DYNJS0900, UDI/DI 40884389235110 (each), 10884389235119 (case), Lot Numbers: 23KBF916; 130) REF GSD349J, UDI/DI 40884389921709 (each), 10884389921708 (case), Lot Numbers: 23LBM389; 131) REF KC4716D, UDI/DI 40888277200914 (each), 10888277200913 (case), Lot Numbers: 23LBL672; 132) REF LYN030DBEYA, UDI/DI 40193489286152 (each), 10193489286151 (case), Lot Numbers: 23LBN466; 133) REF LYN030DBEYA, UDI/DI 40193489286152 (each), 10193489286151 (case), Lot Numbers: 23KBD390; 134) REF MNS13650, UDI/DI 40653160992487 (each), 10653160992486 (case), Lot Numbers: 23LBH905; 135) REF MNS13935A, UDI/DI 40653160996089 (each), 10653160996088 (case), Lot Numbers: 24ABB393; 136) REF MNS15265, UDI/DI 40653160996164 (each), 10653160996163 (case), Lot Numbers: 23LBR564; 137) REF SYNJ910010A, UDI/DI 40889942846987 (each), 10889942846986 (case), Lot Numbers: 24BBI539; 138) REF VAL005BACFA, UDI/DI 40193489261951 (each), 10193489261950 (case), Lot Numbers: 24ABA923; 139) REF VAL009EYCHA, UDI/DI 40193489426077 (each), 10193489426076 (case), Lot Numbers: 24ABA896; 140) REF VAL009TVSGA, UDI/DI 40193489577564 (each), 10193489577563 (case), Lot Numbers: 23LBQ095; 141) REF VAL071GTHFA, UDI/DI 40193489897334 (each), 10193489897333 (case), Lot Numbers: 24ABA928; 142) REF VAL089RIRUA, UDI/DI 40193489438179 (each), 10193489438178 (case), Lot Numbers: 24ABF322

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 20 of 33

Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit

Z-0167-2025
Recall number
Z-0167-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
15 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40653160273586 (each), 10653160273585 (case), Lot Numbers: 24ABB506

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 21 of 33

Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit

Z-0168-2025
Recall number
Z-0168-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
120 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40888277567925 (each), 10888277567924 (case), Lot Numbers: 23LBS908

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 22 of 33

Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit

Z-0169-2025
Recall number
Z-0169-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
150 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40195327108084 (each), 10195327108083 (case), Lot Numbers: 23LBL738

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 23 of 33

Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit

Z-0170-2025
Recall number
Z-0170-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
22 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40195327206087 (each), 10195327206086 (case), Lot Numbers: 24ABG688

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 24 of 33

Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B

Z-0171-2025
Recall number
Z-0171-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
194 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) REF DYNJ44114, UDI/DI 40888277202055 (each), 10888277202054 (case), Lot Numbers: 24ABB398; b) REF DYNJ82663B, UDI/DI 40195327544325 (each), 10195327544324 (case), Lot Numbers: 23LBV498

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 25 of 33

Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit

Z-0172-2025
Recall number
Z-0172-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
144 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40195327198153 (each), 10195327198152 (case), Lot Numbers: 23LBO804

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 26 of 33

Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C

Z-0173-2025
Recall number
Z-0173-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
51 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) REF DYNJ37909A, UDI/DI 40193489675451 (each), 10193489675450 (case), Lot Numbers: 24ABG035; b) REF DYNJ40040C, UDI/DI 40889942683971 (each), 10889942683970 (case), Lot Numbers: 23KBB863

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 27 of 33

Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, REF DYNJ0536939R; 6) LABOR & DELIVERY-LF, REF DYNJ07831F; 7) DELIVERY PACK-LF, REF DYNJ09982A; 8) DELIVERY PACK-LF, REF DYNJ09982A; 9) DELIVERY ROOM PACK, REF DYNJ14193C; 10) OB PACK, REF DYNJ17486I; 11) OB PACK, REF DYNJ17486I; 12) DELIVERY PACK, REF DYNJ24339K; 13) DELIVERY PACK, REF DYNJ26935A; 14) DELIVERY PACK, REF DYNJ26935A; 15) OB/DELIVERY ROOM PACK, REF DYNJ27262F; 16) VAGINAL DELIVERY TRAY, REF DYNJ27275; 17) VAGINAL DELIVERY, REF DYNJ28437F; 18) OB PACK, REF DYNJ31817K; 19) OB PACK, REF DYNJ31817K; 20) OB PACK, REF DYNJ36010F; 21) OB PACK, REF DYNJ38804G; 22) VAGINAL PACK, REF DYNJ40037A; 23) VAGINAL DELIVERY, REF DYNJ40170A; 24) VAG RECTAL PACK BWH-LF, REF DYNJ41694B; 25) OB DELIVERY PACK, REF DYNJ41994; 26) DELIVERY BUNDLE KIT, REF DYNJ43370A; 27) DELIVERY ROOM PACK, REF DYNJ44328G; 28) OB PACK, REF DYNJ44500F; 29) DELIVERY PACK, REF DYNJ47621A; 30) OB PACK, REF DYNJ50482G; 31) DELIVERY PACK, REF DYNJ52966C; 32) DELIVERY PACK, REF DYNJ57567; 33) LABOR & DELIVERY PACK, REF DYNJ57598; 34) OB DELIVERY PACK, REF DYNJ60784B; 35) VAGINAL DELIVERY PACK, REF DYNJ61662; 36) VAGINAL DELIVERY PACK, REF DYNJ61662; 37) LABOR AND DELIVERY PACK, REF DYNJ61864A; 38) PK, L&D-VAG DEL-MH, REF DYNJ62512A; 39) PK, L&D-VAG DEL-MH, REF DYNJ62512A; 40) VUWC OB PACK, REF DYNJ64017B; 41) OB PACK, REF DYNJ65525B; 42) VAG DELIVERY PACK, REF DYNJ66415; 43) VAGINAL DELIVERY PACK, REF DYNJ66970; 44) VAG DELIVERY, REF DYNJ67089; 45) VAGINAL DELIVERY PACK, REF DYNJ67111; 46) VAGINAL DELIVERY PACK, REF DYNJ67111; 47) AOMC MIDWIFE PACK, REF DYNJ67588; 48) VAGINAL DELIVERY TRAY, REF DYNJ68131A; 49) DELIVERY L&D PACK-CLEAR LAKE, REF DYNJ68247C; 50) DELIVERY L & D PACK, REF DYNJ68251D; 51) DELIVERY L & D PACK, REF DYNJ68251D; 52) SS VAGINAL DELIVERY PACK, REF DYNJ69512; 53) VAGINAL DELIVERY PACK, REF DYNJ69544A; 54) DELIVERY, REF DYNJ69721; 55) VAGINAL PACK, REF DYNJ69774A; 56) LABOR & DELIVERY PACK, REF DYNJ69833; 57) VAGINAL DELIVERY, REF DYNJ80532A; 58) OB PACK, REF DYNJ81878; 59) VAGINAL DELIVERY DISP PACK, REF DYNJ81917; 60) GENERAL DELIVERY PACK, REF DYNJ82447; 61) VAGINAL DELIVERY PACK, REF DYNJ82489B; 62) OB PACK, REF DYNJ82923; 63) OB PACK III, REF DYNJ82945; 64) OB PACK, REF DYNJ83196; 65) OB PACK, REF DYNJ83515; 66) 3027240 OB DELIVERY PACK, REF DYNJ84730; 67) DELIVERY PACK, REF DYNJ85860; 68) LABOR AND DELIVERY, REF DYNJ907794A; 69) LABOR AND DELIVERY, REF DYNJ907794A; 70) LABOR AND DELIVERY, REF DYNJ907794A; 71) VAGINAL DELIVERY, REF DYNJ908636A; 72) LABOR & DELIVERY PK I-LF, REF DYNJT0104G; 73) PACK VAGINAL DELIVERY, REF HM190A; 74) VAGINAL DELIVERY PACK-LF, REF PHS410140008D; 75) VAGINAL DELIVERY PACK, REF SYNJ10248B; 76) VAGINAL DELIVERY PACK, REF SYNJ10248B

Z-0174-2025
Recall number
Z-0174-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
12,583 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

1) REF DYNJ0213264O, UDI/DI 40193489411912 (each), 10193489411911 (case), Lot Numbers: 23LBP214; 2) REF DYNJ0375486K, UDI/DI 40889942232865 (each), 10889942232864 (case), Lot Numbers: 23LBQ906; 3) REF DYNJ0375486K, UDI/DI 40889942232865 (each), 10889942232864 (case), Lot Numbers: 23KBO506; 4) REF DYNJ04865M, UDI/DI 40195327188123 (each), 10195327188122 (case), Lot Numbers: 23LBP871; 5) REF DYNJ0536939R, UDI/DI 40195327206223 (each), 10195327206222 (case), Lot Numbers: 24ABC134; 6) REF DYNJ07831F, UDI/DI 40888277841131 (each), 10888277841130 (case), Lot Numbers: 24ABK556; 7) REF DYNJ09982A, UDI/DI 40888277860521 (each), 10888277860520 (case), Lot Numbers: 24ABE463; 8) REF DYNJ09982A, UDI/DI 40888277860521 (each), 10888277860520 (case), Lot Numbers: 23KBF261; 9) REF DYNJ14193C, UDI/DI 40195327410002 (each), 10195327410001 (case), Lot Numbers: 24ABA112; 10) REF DYNJ17486I, UDI/DI 40195327224388 (each), 10195327224387 (case), Lot Numbers: 23LBM930; 11) REF DYNJ17486I, UDI/DI 40195327224388 (each), 10195327224387 (case), Lot Numbers: 23KBF343; 12) REF DYNJ24339K, UDI/DI 40195327597352 (each), 10195327597351 (case), Lot Numbers: 24ABB322; 13) REF DYNJ26935A, UDI/DI 40080196655138 (each), 10080196655137 (case), Lot Numbers: 24ABF439; 14) REF DYNJ26935A, UDI/DI 40080196655138 (each), 10080196655137 (case), Lot Numbers: 23KBF264; 15) REF DYNJ27262F, UDI/DI 40195327302925 (each), 10195327302924 (case), Lot Numbers: 23LBR393; 16) REF DYNJ27275, UDI/DI 40080196833116 (each), 10080196833115 (case), Lot Numbers: 24ABF229; 17) REF DYNJ28437F, UDI/DI 40193489800518 (each), 10193489800517 (case), Lot Numbers: 23LBP215; 18) REF DYNJ31817K, UDI/DI 40195327502172 (each), 10195327502171 (case), Lot Numbers: 24ABE494; 19) REF DYNJ31817K, UDI/DI 40195327502172 (each), 10195327502171 (case), Lot Numbers: 24ABE736; 20) REF DYNJ36010F, UDI/DI 40195327409907 (each), 10195327409906 (case), Lot Numbers: 23KBO470; 21) REF DYNJ38804G, UDI/DI 40195327113101 (each), 10195327113100 (case), Lot Numbers: 24ABF285; 22) REF DYNJ40037A, UDI/DI 40889942253792 (each), 10889942253791 (case), Lot Numbers: 23KBD900; 23) REF DYNJ40170A, UDI/DI 40195327007981 (each), 10195327007980 (case), Lot Numbers: 24ABH933; 24) REF DYNJ41694B, UDI/DI 40193489662819 (each), 10193489662818 (case), Lot Numbers: 23KBI386; 25) REF DYNJ41994, UDI/DI 40884389912509 (each), 10884389912508 (case), Lot Numbers: 23KBM567; 26) REF DYNJ43370A, UDI/DI 40888277854124 (each), 10888277854123 (case), Lot Numbers: 24ABE458; 27) REF DYNJ44328G, UDI/DI 40195327165940 (each), 10195327165949 (case), Lot Numbers: 24ABA443; 28) REF DYNJ44500F, UDI/DI 40193489905497 (each), 10193489905496 (case), Lot Numbers: 24ABG242; 29) REF DYNJ47621A, UDI/DI 40193489203418 (each), 10193489203417 (case), Lot Numbers: 23LBM902; 30) REF DYNJ50482G, UDI/DI 40195327190188 (each), 10195327190187 (case), Lot Numbers: 24ABE007; 31) REF DYNJ52966C, UDI/DI 40193489237154 (each), 10193489237153 (case), Lot Numbers: 23LBP186; 32) REF DYNJ57567, UDI/DI 40889942753209 (each), 10889942753208 (case), Lot Numbers: 23LBP083; 33) REF DYNJ57598, UDI/DI 40889942756248 (each), 10889942756247 (case), Lot Numbers: 24ABN293; 34) REF DYNJ60784B, UDI/DI 40195327456444 (each), 10195327456443 (case), Lot Numbers: 23KBD079; 35) REF DYNJ61662, UDI/DI 40193489587303 (each), 10193489587302 (case), Lot Numbers: 24ABA680; 36) REF DYNJ61662, UDI/DI 40193489587303 (each), 10193489587302 (case), Lot Numbers: 23LBP067; 37) REF DYNJ61864A, UDI/DI 40195327213481 (each), 10195327213480 (case), Lot Numbers: 23LBM885; 38) REF DYNJ62512A, UDI/DI 40193489410007 (each), 10193489410006 (case), Lot Numbers: 23LBN089; 39) REF DYNJ62512A, UDI/DI 40193489410007 (each), 10193489410006 (case), Lot Numbers: 23KBC461; 40) REF DYNJ64017B, UDI/DI 40195327550326 (each), 10195327550325 (case), Lot Numbers: 24ABC789; 41) REF DYNJ65525B, UDI/DI 40195327403332 (each), 10195327403331 (case), Lot Numbers: 23LBP080; 42) REF DYNJ66415, UDI/DI 40193489353182 (each), 10193489353181 (case), Lot Numbers: 23KBE863; 43) REF DYNJ66970, UDI/DI 40193489384636 (each), 10193489384635 (case), Lot Numbers: 24ABA626; 44) REF DYNJ67089, UDI/DI 40193489385497 (each), 10193489385496 (case), Lot Numbers: 23KBF696; 45) REF DYNJ67111, UDI/DI 40193489387354 (each), 10193489387353 (case), Lot Numbers: 24ABB663; 46) REF DYNJ67111, UDI/DI 40193489387354 (each), 10193489387353 (case), Lot Numbers: 23KBB422; 47) REF DYNJ67588, UDI/DI 40193489416931 (each), 10193489416930 (case), Lot Numbers: 24ABE006; 48) REF DYNJ68131A, UDI/DI 40195327453849 (each), 10195327453848 (case), Lot Numbers: 23LBS187; 49) REF DYNJ68247C, UDI/DI 40195327507665 (each), 10195327507664 (case), Lot Numbers: 23KBF880; 50) REF DYNJ68251D, UDI/DI 40195327506460 (each), 10195327506469 (case), Lot Numbers: 23LBM746; 51) REF DYNJ68251D, UDI/DI 40195327506460 (each), 10195327506469 (case), Lot Numbers: 23KBE824; 52) REF DYNJ69512, UDI/DI 40193489949248 (each), 10193489949247 (case), Lot Numbers: 23LBP605; 53) REF DYNJ69544A, UDI/DI 40195327325368 (each), 10195327325367 (case), Lot Numbers: 23LBU620; 54) REF DYNJ69721, UDI/DI 40193489973076 (each), 10193489973075 (case), Lot Numbers: 24ABA088; 55) REF DYNJ69774A, UDI/DI 40195327328369 (each), 10195327328368 (case), Lot Numbers: 23KBM418; 56) REF DYNJ69833, UDI/DI 40193489983419 (each), 10193489983418 (case), Lot Numbers: 23LBP238; 57) REF DYNJ80532A, UDI/DI 40195327064649 (each), 10195327064648 (case), Lot Numbers: 23KBD408; 58) REF DYNJ81878, UDI/DI 40195327153572 (each), 10195327153571 (case), Lot Numbers: 23LBR963; 59) REF DYNJ81917, UDI/DI 40195327155347 (each), 10195327155346 (case), Lot Numbers: 24ABG346; 60) REF DYNJ82447, UDI/DI 40195327196951 (each), 10195327196950 (case), Lot Numbers: 23KBF548; 61) REF DYNJ82489B, UDI/DI 40195327361298 (each), 10195327361297 (case), Lot Numbers: 23LBJ943; 62) REF DYNJ82923, UDI/DI 40195327219421 (each), 10195327219420 (case), Lot Numbers: 24ABG248; 63) REF DYNJ82945, UDI/DI 40195327218868 (each), 10195327218867 (case), Lot Numbers: 23LBP176; 64) REF DYNJ83196, UDI/DI 40195327243976 (each), 10195327243975 (case), Lot Numbers: 24ABE294; 65) REF DYNJ83515, UDI/DI 40195327275045 (each), 10195327275044 (case), Lot Numbers: 24ABD211; 66) REF DYNJ84730, UDI/DI 40195327407712 (each), 10195327407711 (case), Lot Numbers: 23LBN461; 67) REF DYNJ85860, UDI/DI 40195327560233 (each), 10195327560232 (case), Lot Numbers: 23LBP250; 68) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 24EBF501; 69) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 24BBS293; 70) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 23KBT943; 71) REF DYNJ908636A, UDI/DI 40195327314980 (each), 10195327314989 (case), Lot Numbers: 23LBE142; 72) REF DYNJT0104G, UDI/DI 40889942741442 (each), 10889942741441 (case), Lot Numbers: 23LBL842; 73) REF HM190A, UDI/DI 40195327305162 (each), 10195327305161 (case), Lot Numbers: 23LBP164; 74) REF PHS410140008D, UDI/DI 40195327503131 (each), 10195327503130 (case), Lot Numbers: 23KBS958; 75) REF SYNJ10248B, UDI/DI 40193489373388 (each), 10193489373387 (case), Lot Numbers: 24ABA624; 76) REF SYNJ10248B, UDI/DI 40193489373388 (each), 10193489373387 (case), Lot Numbers: 23KBE181

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 28 of 33

Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707

Z-0175-2025
Recall number
Z-0175-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
197 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) REF DYNJ24362C, UDI/DI 40889942830054 (each), 10889942830053 (case), Lot Numbers: 24ABG207; b) REF DYNJ46774B, UDI/DI 40889942582748 (each), 10889942582747 (case), Lot Numbers: 23LBN531; c) REF DYNJ84509, UDI/DI 40195327372881 (each), 10195327372880 (case), Lot Numbers: 23LBL712; d) REF DYNJ907707, UDI/DI 40193489848978 (each), 10193489848977 (case), Lot Numbers: 24ABR224

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 29 of 33

Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750

Z-0176-2025
Recall number
Z-0176-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
88 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) REF DYNJ46730, UDI/DI 40888277597199 (each), 10888277597198 (case), Lot Numbers: 23LBP056; b) REF DYNJ49302A, UDI/DI 40888277843395 (each), 10888277843394 (case), Lot Numbers: 24ABG706; c) REF DYNJ57526A, UDI/DI 40193489630931 (each), 10193489630930 (case), Lot Numbers: 23LBL679; d) REF DYNJ68750, UDI/DI 40193489836586 (each), 10193489836585 (case), Lot Numbers: 24ABB984

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 30 of 33

Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB PACK, REF DYNJ42884; h) RFT D & C PACK, REF DYNJ50851; i) KIT OB, REF DYNJ906623; j) D AND C, REF DYNJ907957A; k) CHS OB PACK III, REF DYNJCH907

Z-0177-2025
Recall number
Z-0177-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
1506 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

a) REF DYNJ0912449M, UDI/DI 40889942437536 (each), 10889942437535 (case), Lot Numbers: 23LBP185; b) REF DYNJ17309G, UDI/DI 40193489277181 (each), 10193489277180 (case), Lot Numbers: 24ABB399; c) REF DYNJ34268D, UDI/DI 40193489821421 (each), 10193489821420 (case), Lot Numbers: 23LBM844; d) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers: 23LBS099; e) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers: 23KBB869; f) REF DYNJ39668I, UDI/DI 40195327456284 (each), 10195327456283 (case), Lot Numbers: 23LBM868; g) REF DYNJ42884, UDI/DI 40888277011077 (each), 10888277011076 (case), Lot Numbers: 23KBB574; h) REF DYNJ50851, UDI/DI 40889942029014 (each), 10889942029013 (case), Lot Numbers: 23LBL975; i) REF DYNJ906623, UDI/DI 40193489794695 (each), 10193489794694 (case), Lot Numbers: 24ABE587; j) REF DYNJ907957A, UDI/DI 40195327189854 (each), 10195327189853 (case), Lot Numbers: 24BBA954; k) REF DYNJCH907, UDI/DI 40193489391979 (each), 10193489391978 (case), Lot Numbers: 24ABC904

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 31 of 33

Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A; 8) CATARACT PACK WRO-LF, REF DYNJ41861; 9) EYE PACK, REF DYNJ43911; 10) PHACO PACK, REF DYNJ44748I; 11) DR DRUMMOND EYE PACK, REF DYNJ45344G; 12) OPHTHALMIC PACK, REF DYNJ47275A; 13) CATARACT PACK, REF DYNJ49412B; 14) CATARACT PACK, REF DYNJ50948A; 15) CATARACT PACK, REF DYNJ50948A; 16) CATARACT DR MALONE PACK, REF DYNJ51590A; 17) CATARACT DR MALONE PACK, REF DYNJ51590A; 18) CUSTOM EYE TRAY, REF DYNJ51821B; 19) EYE SURGERY PACK, REF DYNJ53097C; 20) CATARACT KIT, REF DYNJ53944; 21) EYE PACK, REF DYNJ54847D; 22) PK, OPHTH-EYE, REF DYNJ55070B; 23) EYE PACK, REF DYNJ55320D; 24) PK, OPHTH-RETINA, REF DYNJ59253B; 25) RETINA PACK, REF DYNJ60515; 26) ASED KIT, REF DYNJ60745D; 27) CATARACT PACK, REF DYNJ61321B; 28) EYE PACK, REF DYNJ61862A; 29) CATARACT PACK DR FREDERICK, REF DYNJ63163; 30) CATARACT DR ESTOPINAL, REF DYNJ63164; 31) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 32) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 33) HMSL EYE PACK, REF DYNJ64537A; 34) EYE PACK, REF DYNJ65271C; 35) CMC ODS OPHTHALMIC PACK, REF DYNJ66832; 36) BASIC CATARACT PACK, REF DYNJ69165D; 37) BASIC CATARACT PACK, REF DYNJ69165D; 38) LIFESPAN VITRECTOMY PACK, REF DYNJ80082; 39) CATARACT PACK WITH NO TUB, REF DYNJ80232; 40) RETINA PACK, REF DYNJ80483; 41) RETINA PACK, REF DYNJ81640; 42) WESTFALL OCCUPLASTY, REF DYNJ81796A; 43) EYE PACK, REF DYNJ83799C; 44) OPHTHALMIC PACK, REF DYNJ85275; 45) CATARACT, REF DYNJ908059A; 46) EYE TRAY 1-LF, REF LLSCAEYE01A; 47) PHACO PACK, REF LYN011PHNHD; 48) PHACO PACK, REF LYN011PHNHD; 49) SPECIALTY BESSER PACK, REF LYN023BPSSD; 50) SPECIALTY BESSER PACK, REF LYN023BPSSD; 51) SPECIALTY BESSER PACK, REF LYN023BPSSD; 52) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 53) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 54) OPHTHALMIC PACK, REF LYN023OPSOB; 55) CATARACT PACK CLEARSIGHT CTR, REF LYN024CACSB; 56) BASIC CATARACT PACK, REF LYN030BCSDB; 57) CATARACT PACK SEVEN SPRINGS, REF LYN030CPSSA; 58) AIKEN CATARACT PACK II, REF LYN030CTAKG; 59) AIKEN CATARACT PACK II, REF LYN030CTAKG; 60) AIKEN CATARACT PACK II, REF LYN030CTAKG; 61) VA EYE II-LF, REF LYN030VAEYA; 62) VA EYE II-LF, REF LYN030VAEYA; 63) CATARACT PACK, REF LYN035CTSEC; 64) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 65) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 66) OPHTHALMIC PACK, REF LYN041OPFCC; 67) OPHTHALMIC PACK, REF LYN041OPFCC; 68) OPHTHALMIC PACK, REF LYN041OPFCC; 69) OPHTHALMIC PACK, REF LYN041OPFCC; 70) CATARACT PACK, REF LYN042CPFEG; 71) OPTHALMIC PACK-LF, REF PHS529724000B; 72) CATARACT PACK, REF VAL001CPMEB; 73) CATARACT PACK, REF VAL001CPMEB; 74) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 75) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 76) RETINA PACK PIEDMONT EYE, REF VAL003REPEA; 77) CATARACT PACK, REF VAL009CAAHC; 78) RENAISSANCE CAT PACK, REF VAL009CAREA; 79) CATARACT TENAYA SURGERY CENTER, REF VAL009CATEA; 80) CATARACT PACK, REF VAL009CTSGA; 81) DOUGHERTY LASER VISION- NEW II, REF VAL009EYDLC; 82) RETINA PACK-TRINITY GROUP, REF VAL009RETGA; 83) RENAISSANCE VIT PACK, REF VAL009VIREA; 84) CATARACT PACK APERTURE, REF VAL011CTVAA; 85) OPHTHALMIC PACK, REF VAL022BSOMD; 86) CATARACT PACK - INST OF OKLA, REF VAL024CAIOD; 87) EYE PACK, REF VAL024EYTRB; 88) CATARACT PACK, REF VAL026CTNFC; 89) EYE PACK, REF VAL029EYGSB; 90) INTRAOCULAR PACK, REF VAL031IOGCB; 91) CATARACT, REF VAL035CPAEC; 92) CATARACT PACK 2, REF VAL036CABRD; 93) BRINTON VISION ICL PACK, REF VAL037ICBVG; 94) EYE PACK, REF VAL038BSCID; 95) CATARACT PACK EYECARE CONSULT, REF VAL038CTECB; 96) EYE PACK SC OF SOUTHWOODS, REF VAL041EPSWA; 97) BOOZMAN HOF PACK 2, REF VAL042EYBHC; 98) CATARACT PACK WILD

Z-0178-2025
Recall number
Z-0178-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
27,906 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

1) REF DYNJ19492L, UDI/DI 40195327368587 (each), 10195327368586 (case), Lot Numbers: 24ABE741; 2) REF DYNJ22354L, UDI/DI 40195327239924 (each), 10195327239923 (case), Lot Numbers: 23LBN139; 3) REF DYNJ24573K, UDI/DI 40195327144303 (each), 10195327144302 (case), Lot Numbers: 23KBB931; 4) REF DYNJ30327A, UDI/DI 40193489997089 (each), 10193489997088 (case), Lot Numbers: 24ABB714; 5) REF DYNJ36868F, UDI/DI 40888277897060 (each), 10888277897069 (case), Lot Numbers: 23KBD160; 6) REF DYNJ40811A, UDI/DI 40888277014634 (each), 10888277014633 (case), Lot Numbers: 23KBE584; 7) REF DYNJ41769A, UDI/DI 40888277267825 (each), 10888277267824 (case), Lot Numbers: 23KBB744; 8) REF DYNJ41861, UDI/DI 40888277020741 (each), 10888277020740 (case), Lot Numbers: 23KBB746; 9) REF DYNJ43911, UDI/DI 40888277073617 (each), 10888277073616 (case), Lot Numbers: 23LBQ741; 10) REF DYNJ44748I, UDI/DI 40193489273459 (each), 10193489273458 (case), Lot Numbers: 23LBP074; 11) REF DYNJ45344G, UDI/DI 40195327402922 (each), 10195327402921 (case), Lot Numbers: 23LBU068; 12) REF DYNJ47275A, UDI/DI 40888277571946 (each), 10888277571945 (case), Lot Numbers: 24ABE470; 13) REF DYNJ49412B, UDI/DI 40889942935278 (each), 10889942935277 (case), Lot Numbers: 24ABD256; 14) REF DYNJ50948A, UDI/DI 40195327117550 (each), 10195327117559 (case), Lot Numbers: 24ABC786; 15) REF DYNJ50948A, UDI/DI 40195327117550 (each), 10195327117559 (case), Lot Numbers: 23KBA350; 16) REF DYNJ51590A, UDI/DI 40193489721387 (each), 10193489721386 (case), Lot Numbers: 23LBN087; 17) REF DYNJ51590A, UDI/DI 40193489721387 (each), 10193489721386 (case), Lot Numbers: 23KBE531; 18) REF DYNJ51821B, UDI/DI 40193489963374 (each), 10193489963373 (case), Lot Numbers: 23KBE568; 19) REF DYNJ53097C, UDI/DI 40889942721376 (each), 10889942721375 (case), Lot Numbers: 24ABC180; 20) REF DYNJ53944, UDI/DI 40889942450689 (each), 10889942450688 (case), Lot Numbers: 23LBR325; 21) REF DYNJ54847D, UDI/DI 40193489266659 (each), 10193489266658 (case), Lot Numbers: 23LBI510; 22) REF DYNJ55070B, UDI/DI 40193489800686 (each), 10193489800685 (case), Lot Numbers: 23LBU001; 23) REF DYNJ55320D, UDI/DI 40195327429219 (each), 10195327429218 (case), Lot Numbers: 24ABD339; 24) REF DYNJ59253B, UDI/DI 40193489269322 (each), 10193489269321 (case), Lot Numbers: 24ABB328; 25) REF DYNJ60515, UDI/DI 40193489510240 (each), 10193489510249 (case), Lot Numbers: 24ABE890; 26) REF DYNJ60745D, UDI/DI 40193489949309 (each), 10193489949308 (case), Lot Numbers: 24ABA754; 27) REF DYNJ61321B, UDI/DI 40193489794411 (each), 10193489794410 (case), Lot Numbers: 23KBF225; 28) REF DYNJ61862A, UDI/DI 40195327216826 (each), 10195327216825 (case), Lot Numbers: 23KBC772; 29) REF DYNJ63163, UDI/DI 40193489721585 (each), 10193489721584 (case), Lot Numbers: 23LBL330; 30) REF DYNJ63164, UDI/DI 40193489721592 (each), 10193489721591 (case), Lot Numbers: 23LBN120; 31) REF DYNJ63272C, UDI/DI 40195327532254 (each), 10195327532253 (case), Lot Numbers: 24ABC862; 32) REF DYNJ63272C, UDI/DI 40195327532254 (each), 10195327532253 (case), Lot Numbers: 23KBI662; 33) REF DYNJ64537A, UDI/DI 40195327518494 (each), 10195327518493 (case), Lot Numbers: 24ABC540; 34) REF DYNJ65271C, UDI/DI 40193489957946 (each), 10193489957945 (case), Lot Numbers: 23KBC696; 35) REF DYNJ66832, UDI/DI 40193489389051 (each), 10193489389050 (case), Lot Numbers: 23KBE083; 36) REF DYNJ69165D, UDI/DI 40195327224340 (each), 10195327224349 (case), Lot Numbers: 23LBP941; 37) REF DYNJ69165D, UDI/DI 40195327224340 (each), 10195327224349 (case), Lot Numbers: 23KBE571; 38) REF DYNJ80082, UDI/DI 40195327012008 (each), 10195327012007 (case), Lot Numbers: 24ABD342; 39) REF DYNJ80232, UDI/DI 40195327017065 (each), 10195327017064 (case), Lot Numbers: 23LBN193; 40) REF DYNJ80483, UDI/DI 40195327045341 (each), 10195327045340 (case), Lot Numbers: 24ABC583; 41) REF DYNJ81640, UDI/DI 40195327129478 (each), 10195327129477 (case), Lot Numbers: 23LBK169; 42) REF DYNJ81796A, UDI/DI 40195327570386 (each), 10195327570385 (case), Lot Numbers: 23LBN670; 43) REF DYNJ83799C, UDI/DI 40195327443932 (each), 10195327443931 (case), Lot Numbers: 23LBP953; 44) REF DYNJ85275, UDI/DI 40195327484690 (each), 10195327484699 (case), Lot Numbers: 24ABA128; 45) REF DYNJ908059A, UDI/DI 40195327125432 (each), 10195327125431 (case), Lot Numbers: 23LBT833; 46) REF LLSCAEYE01A, UDI/DI 40884389376981 (each), 10884389376980 (case), Lot Numbers: 23KBB457; 47) REF LYN011PHNHD, UDI/DI 40193489234405 (each), 10193489234404 (case), Lot Numbers: 24ABD326; 48) REF LYN011PHNHD, UDI/DI 40193489234405 (each), 10193489234404 (case), Lot Numbers: 24ABA918; 49) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers: 24ABA470; 50) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers: 23LBN465; 51) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers: 23KBF760; 52) REF LYN023BSBLB, UDI/DI 40889942336242 (each), 10889942336241 (case), Lot Numbers: 24ABC586; 53) REF LYN023BSBLB, UDI/DI 40889942336242 (each), 10889942336241 (case), Lot Numbers: 24ABD327; 54) REF LYN023OPSOB, UDI/DI 40889942375791 (each), 10889942375790 (case), Lot Numbers: 24ABD328; 55) REF LYN024CACSB, UDI/DI 40195327095735 (each), 10195327095734 (case), Lot Numbers: 23LBN673; 56) REF LYN030BCSDB, UDI/DI 40193489457965 (each), 10193489457964 (case), Lot Numbers: 24ABH583; 57) REF LYN030CPSSA, UDI/DI 40195327128549 (each), 10195327128548 (case), Lot Numbers: 23KBD385; 58) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers: 24ABA502; 59) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers: 23LBP443; 60) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers: 23LBQ089; 61) REF LYN030VAEYA, UDI/DI 40195327242917 (each), 10195327242916 (case), Lot Numbers: 24ABA893; 62) REF LYN030VAEYA, UDI/DI 40195327242917 (each), 10195327242916 (case), Lot Numbers: 24ABD329; 63) REF LYN035CTSEC, UDI/DI 40889942532026 (each), 10889942532025 (case), Lot Numbers: 23KBC621; 64) REF LYN037DBEYM, UDI/DI 40193489473910 (each), 10193489473919 (case), Lot Numbers: 23LBQ090; 65) REF LYN037DBEYM, UDI/DI 40193489473910 (each), 10193489473919 (case), Lot Numbers: 23KBD746; 66) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 24ABD867; 67) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 23LBN722; 68) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 23LBA842; 69) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 23KBD251; 70) REF LYN042CPFEG, UDI/DI 40193489219372 (each), 10193489219371 (case), Lot Numbers: 23KBC622; 71) REF PHS529724000B, UDI/DI 40195327166022 (each), 10195327166021 (case), Lot Numbers: 23KBE642; 72) REF VAL001CPMEB, UDI/DI 40195327205455 (each), 10195327205454 (case), Lot Numbers: 24ABE054; 73) REF VAL001CPMEB, UDI/DI 40195327205455 (each), 10195327205454 (case), Lot Numbers: 23LBH892; 74) REF VAL002CATSG, UDI/DI 40195327250417 (each), 10195327250416 (case), Lot Numbers: 24ABN974; 75) REF VAL002CATSG, UDI/DI 40195327250417 (each), 10195327250416 (case), Lot Numbers: 23KBC653; 76) REF VAL003REPEA, UDI/DI 40889942968382 (each), 10889942968381 (case), Lot Numbers: 24ABF774; 77) REF VAL009CAAHC, UDI/DI 40195327260300 (each), 10195327260309 (case), Lot Numbers: 23KBB402; 78) REF VAL009CAREA, UDI/DI 40193489462242 (each), 10193489462241 (case), Lot Numbers: 23KBC624; 79) REF VAL009CATEA, UDI/DI 40889942872399 (each), 10889942872398 (case), Lot Numbers: 24ABA924; 80) REF VAL009CTSGA, UDI/DI 40193489577540 (each), 10193489577549 (case), Lot Numbers: 24ABA478; 81) REF VAL009EYDLC, UDI/DI 40195327302291 (each), 10195327302290 (case), Lot Numbers: 24ABE052; 82) REF VAL009RETGA, UDI/DI 40193489676991 (each), 10193489676990 (case), Lot Numbers: 23LBQ654; 83) REF VAL009VIREA, UDI/DI 40193489462259 (each), 10193489462258 (case), Lot Numbers: 24ABA925; 84) REF VAL011CTVAA, UDI/DI 40889942005568 (each), 10889942005567 (case), Lot Numbers: 23KBC625; 85) REF VAL022BSOMD, UDI/DI 40889942760214 (each), 10889942760213 (case), Lot Numbers: 23LBQ097; 86) REF VAL024CAIOD, UDI/DI 40193489491525 (each), 10193489491524 (case), Lot Numbers: 23KBB700; 87) REF VAL024EYTRB, UDI/DI 40193489426008 (each), 10193489426007 (case), Lot Numbers: 23LBN467; 88) REF VAL026CTNFC, UDI/DI 40193489458412 (each), 10193489458411 (case), Lot Numbers: 23LBA843; 89) REF VAL029EYGSB, UDI/DI 40193489550727 (each), 10193489550726 (case), Lot Numbers: 23KBT152; 90) REF VAL031IOGCB, UDI/DI 40889942307198 (each), 10889942307197 (case), Lot Numbers: 24ABA898; 91) REF VAL035CPAEC, UDI/DI 40889942537373 (each), 10889942537372 (case), Lot Numbers: 23KBE643; 92) REF VAL036CABRD, UDI/DI 40195327196159 (each), 10195327196158 (case), Lot Numbers: 23KBC657; 93) REF VAL037ICBVG, UDI/DI 40193489868136 (each), 10193489868135 (case), Lot Numbers: 23KBC628; 94) REF VAL038BSCID, UDI/DI 40888277761767 (each), 10888277761766 (case), Lot Numbers: 23KBC629; 95) REF VAL038CTECB, UDI/DI 40889942867883 (each), 10889942867882 (case), Lot Numbers: 23LBP453; 96) REF VAL041EPSWA, UDI/DI 40193489394550 (each), 10193489394559 (case), Lot Numbers: 24ABA469; 97) REF VAL042EYBHC, UDI/DI 40195327033249 (each), 10195327033248 (case), Lot Numbers: 23KBD595; 98) REF VAL046CAWCA, UDI/DI 40193489846721 (each), 10193489846720 (case), Lot Numbers: 23LBM013; 99) REF VAL047VIVOA, UDI/DI 40193489375122 (each), 10193489375121 (case), Lot Numbers: 23LBM392; 100) REF VAL048TSCCA, UDI/DI 40195327250455 (each), 10195327250454 (case), Lot Numbers: 23LBQ099; 101) REF VAL048TSCCA, UDI/DI 40195327250455 (each), 10195327250454 (case), Lot Numbers: 23KBC660; 102) REF VAL050CTFEI, UDI/DI 40193489368063 (each), 10193489368062 (case), Lot Numbers: 24ABA899; 103) REF VAL050EEPKB, UDI/DI 40195327267149 (each), 10195327267148 (case), Lot Numbers: 24ABA472; 104) REF VAL050ITKEA, UDI/DI 40195327134090 (each), 10195327134099 (case), Lot Numbers: 23KBK068; 105) REF VAL050REBOB, UDI/DI 40193489833653 (each), 10193489833652 (case), Lot Numbers: 24ABA477; 106) REF VAL050VIAHD, UDI/DI 40195327195565 (each), 10195327195564 (case), Lot Numbers: 23JBU308; 107) REF VAL054CAMAA, UDI/DI 40193489228114 (each), 10193489228113 (case), Lot Numbers: 23LBQ100; 108) REF VAL059DKSWB, UDI/DI 40193489667951 (each), 10193489667950 (case), Lot Numbers: 23KBE384; 109) REF VAL075EYLSA, UDI/DI 40889942804345 (each), 10889942804344 (case), Lot Numbers: 23LBP466; 110) REF VAL089EYRUA, UDI/DI 40193489438162 (each), 10193489438161 (case), Lot Numbers: 23LBP468

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 32 of 33

Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAVIGATIONAL SPINE FUSION, REF DYNJ45153B; 7) FEET, ELBOW, AND ANKLE TEGH-LF, REF DYNJ46719B; 8) PLASTIC HAND PACK TEGH-LF, REF DYNJ46739B; 9) CVL INSERTION KIT-LF, REF DYNJ48587A; 10) CVL INSERTION KIT-LF, REF DYNJ48587A; 11) ENSEMBLE SURPLUS LCA-LF, REF DYNJ48892C; 12) EXTREMITY PACK, REF DYNJ49301B; 13) ACL ACCESSORY PACK, REF DYNJ50952F; 14) SPINAL INJECTION PACK, REF DYNJ51383F; 15) FTMC ARTHROS BASIC SETUP-LF, REF DYNJ54602A; 16) MINOR EXTREMITY PACK, REF DYNJ55324G; 17) MINOR EXTREMITY PACK, REF DYNJ55324G; 18) D-SPINE SUPPLEMENT PACK, REF DYNJ58115A; 19) EXTREMITY PACK, REF DYNJ62877; 20) AHT LG KNEE ROLL, REF DYNJ64823; 21) CUSTOM ORTHO PACK, REF DYNJ83675; 22) DR SUNDAR SCS KIT, REF DYNJ85288A; 23) CENTRAL SCS TRIAL PACK, REF DYNJ85503; 24) TOTAL KNEE CDS-LF, REF DYNJ909569; 25) EXTREMITY PACK, REF SYNJ10253B; 26) CARROLLTON HIP FX, REF SYNJ910003A; 27) ARTHROSCOPY, REF SYNJ910004C

Z-0179-2025
Recall number
Z-0179-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
2371 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

1) REF CDS982519W, UDI/DI 40195327389971 (each), 10195327389970 (case), Lot Numbers: 24BBQ775; 2) REF CDS984003A, UDI/DI 40888277002891 (each), 10888277002890 (case), Lot Numbers: 24ABG354; 3) REF DYNJ32639C, UDI/DI 40889942919223 (each), 10889942919222 (case), Lot Numbers: 23KBE944; 4) REF DYNJ39547B, UDI/DI 40193489760485 (each), 10193489760484 (case), Lot Numbers: 23LBO506; 5) REF DYNJ41229C, UDI/DI 40195327609727 (each), 10195327609726 (case), Lot Numbers: 24ABK563; 6) REF DYNJ45153B, UDI/DI 40195327235414 (each), 10195327235413 (case), Lot Numbers: 24ABD667; 7) REF DYNJ46719B, UDI/DI 40889942279303 (each), 10889942279302 (case), Lot Numbers: 23LBP194; 8) REF DYNJ46739B, UDI/DI 40889942314318 (each), 10889942314317 (case), Lot Numbers: 24ABG221; 9) REF DYNJ48587A, UDI/DI 40889942313106 (each), 10889942313105 (case), Lot Numbers: 23LBO732; 10) REF DYNJ48587A, UDI/DI 40889942313106 (each), 10889942313105 (case), Lot Numbers: 23KBO606; 11) REF DYNJ48892C, UDI/DI 40889942791768 (each), 10889942791767 (case), Lot Numbers: 23KBB893; 12) REF DYNJ49301B, UDI/DI 40889942686613 (each), 10889942686612 (case), Lot Numbers: 24ABB592; 13) REF DYNJ50952F, UDI/DI 40193489361668 (each), 10193489361667 (case), Lot Numbers: 23LBV189; 14) REF DYNJ51383F, UDI/DI 40193489225588 (each), 10193489225587 (case), Lot Numbers: 23LBS071; 15) REF DYNJ54602A, UDI/DI 40195327456673 (each), 10195327456672 (case), Lot Numbers: 23LBO084; 16) REF DYNJ55324G, UDI/DI 40195327433964 (each), 10195327433963 (case), Lot Numbers: 23LBL961; 17) REF DYNJ55324G, UDI/DI 40195327433964 (each), 10195327433963 (case), Lot Numbers: 23KBE137; 18) REF DYNJ58115A, UDI/DI 40195327582037 (each), 10195327582036 (case), Lot Numbers: 23LBL852; 19) REF DYNJ62877, UDI/DI 40193489695824 (each), 10193489695823 (case), Lot Numbers: 23LBV377; 20) REF DYNJ64823, UDI/DI 40193489221054 (each), 10193489221053 (case), Lot Numbers: 23LBK801; 21) REF DYNJ83675, UDI/DI 40195327296408 (each), 10195327296407 (case), Lot Numbers: 24ABG702; 22) REF DYNJ85288A, UDI/DI 40195327543083 (each), 10195327543082 (case), Lot Numbers: 24ABG603; 23) REF DYNJ85503, UDI/DI 40195327509904 (each), 10195327509903 (case), Lot Numbers: 23LBS030; 24) REF DYNJ909569, UDI/DI 40195327399703 (each), 10195327399702 (case), Lot Numbers: 24BBF009; 25) REF SYNJ10253B, UDI/DI 40193489373593 (each), 10193489373592 (case), Lot Numbers: 24ABG182; 26) REF SYNJ910003A, UDI/DI 40889942848448 (each), 10889942848447 (case), Lot Numbers: 24ABW931; 27) REF SYNJ910004C, UDI/DI 40195327246748 (each), 10195327246747 (case), Lot Numbers: 24BBC876

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

device · product 33 of 33

Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit

Z-0180-2025
Recall number
Z-0180-2025
Initiated
September 04, 2024
Classification
Class II
Status
Ongoing
Quantity
160 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile product if the vendor seal of the pouch is opened/unsealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Code information

UDI/DI 40889942863304 (each), 10889942863303 (case), Lot Numbers: 24ABA894

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Field note

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