Medline brand medical procedure convenience kits, labeled as recallZ-0176-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Sep 4, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.
Recall details
- Recall number
- Z-0176-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 4, 2024
- Posted by the FDA
- Oct 23, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 88 units
- Product code
- OJF
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ57526AMedline Industries, Inc. · Hysterectomy kit1 recall0 reports
- Medline Industries, Inc. DYNJ68750Medline Industries, Inc. · Hysterectomy kit1 recall0 reports
- Medline Industries, Inc. DYNJ46730Medline Industries, Inc. · Hysterectomy kit1 recall0 reports
- Medline Industries, Inc. DYNJ49302AMedline Industries, Inc. · Hysterectomy kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95415).
- Z-0148-2025 · Open, ClassifiedCenturion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
- Z-0149-2025 · Open, ClassifiedCenturion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
- Z-0150-2025 · Open, ClassifiedCenturion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
- Z-0151-2025 · Open, ClassifiedCenturion OB TRAY, REF MNS13965A; medical procedure convenience kit
- Z-0152-2025 · Open, ClassifiedMedline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kit
- Z-0153-2025 · Open, ClassifiedMedline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
- Z-0154-2025 · Open, ClassifiedMedline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
- Z-0155-2025 · Open, ClassifiedMedline 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…
- Z-0156-2025 · Open, ClassifiedMedline 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 DYN…
- Z-0157-2025 · Open, ClassifiedMedline 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; …
- Z-0158-2025 · Open, ClassifiedMedline 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…
- Z-0159-2025 · Open, ClassifiedMedline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
- Z-0160-2025 · Open, ClassifiedMedline 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 MICR…
- Z-0161-2025 · Open, ClassifiedMedline 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 …
- Z-0162-2025 · Open, ClassifiedMedline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
- Z-0163-2025 · Open, ClassifiedMedline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
- Z-0164-2025 · Open, ClassifiedMedline 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 F…
- Z-0165-2025 · Open, ClassifiedMedline 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…
- Z-0166-2025 · Open, ClassifiedMedline 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; …
- Z-0167-2025 · Open, ClassifiedMedline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
- Z-0168-2025 · Open, ClassifiedMedline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit
- Z-0169-2025 · Open, ClassifiedMedline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
- Z-0170-2025 · Open, ClassifiedMedline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
- Z-0171-2025 · Open, ClassifiedMedline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
- Z-0173-2025 · Open, ClassifiedMedline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
- Z-0174-2025 · Open, ClassifiedMedline 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…
- Z-0175-2025 · Open, ClassifiedMedline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ8…
- Z-0177-2025 · Open, ClassifiedMedline 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 D…
- Z-0178-2025 · Open, ClassifiedMedline 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 DYNJ303…
- Z-0179-2025 · Open, ClassifiedMedline 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 DYN…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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