MEDLINE Medical Procedure Kits labeled as: 1) CRANI — Class II medical device recall Z-2508-2026

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-2508-2026`
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	3,521 units
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`10193489336238`, `10193489430615`, `10193489973846`, `10195327507077`, `10195327604967`, `10195327606169`, `10198459043499`, `10198459129773`, `10198459237782`, `10198459600197`, `10889942624065`, `10889942886418`, `40193489336239`, `40193489430616`, `40193489973847`, `40195327507078`, `40195327604968`, `40195327606160`, `40198459043490`, `40198459129774`, `40198459237783`, `40198459600198`, `40889942624066`, `40889942886419`
Lot numbers	`21ABM797`, `21ABW707`, `21AMC934`, `21BMA535`, `21CMB156`, `21DMD509`, `21EMF262`, `21FMF742`, `21GMC422`, `21HMB506`, `21HMG155`, `21IBO640`, `21JMB332`, `21JMC555`, `21KBS950`, `21LMD434`, `22ABN864`, `22AME279`, `22BBU902`, `22BBX706`, `22EBB478`, `22EMH976`, `22FBC633`, `22FBR153`, `22GBR089`, `22GMH469`, `22HBT661`, `22JBD615`, `22JBY524`, `22KBM832`, `22LBE875`, `23BBK246`, `23DBM780`, `23EBU086`, `23FBF166`, `23FBQ975`, `23FBS680`, `23GBR436`, `23HBQ073`, `23IBS778` and 44 more

Product

MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097D; 6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029; 7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B; 8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A; 9) LAMI PACK, Medline Kit Number/SKU DYNJ67767; 10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F; 11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q; 12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.

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-2508-2026. 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.