MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK — Class II medical device recall Z-2501-2026

Ongoing recall by Medline Industries, LP, reported 2026-06-24, distributed nationwide. During an internal review, Medline identified representative samples did not meet applicable performance speci

Recall number	`Z-2501-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Medline Industries, LP, Northfield, IL, United States
Recall initiated	2026-05-04
Classified	2026-06-17
Reported by FDA	2026-06-24
Distributed	Nationwide (US)
Quantity	24,388 units
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`10193489352504`, `10193489555820`, `10195327188221`, `10195327191092`, `10195327205980`, `10195327350635`, `10195327408886`, `10195327446635`, `10195327637651`, `10198459485565`, `10198459495823`, `10198459572753`, `10198459676048`, `10889942182589`, `10889942572595`, `40193489352505`, `40193489555821`, `40195327188222`, `40195327191093`, `40195327205981`, `40195327350636`, `40195327408887`, `40195327446636`, `40195327637652`, `40198459485566` and 5 more
Lot numbers	`21ABH741`, `21BBO974`, `21BMC555`, `21CBS171`, `21CMD016`, `21DBJ299`, `21DKA599`, `21EMB753`, `21EMF514`, `21GBE751`, `21GBF157`, `21HBF040`, `21HBR630`, `21IBJ988`, `21JBP278`, `21JBQ328`, `21KBW225`, `21LBI584`, `22ABJ981`, `22BBR963`, `22CBJ210`, `22CBY160`, `22DBF817`, `22DBS732`, `22EMC749`, `22FBW026`, `22GMF232`, `22HBR879`, `22HBU578`, `22HME067`, `22HME796`, `22JBB063`, `22JBH943`, `22JMD634`, `22JMG781`, `22KBA970`, `22KBG024`, `22LBP927`, `22LMG249`, `22OBD819` and 90 more

Product

MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.

Reason for recall

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2501-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.