CLASS II · ModerateFDA

Medline Industries, LP recalls MEDLINE Medical Procedure Kits labeled as: 1) CRANI

📅 May 4, 2026 · 📍 Nationwide

Recalling company: Medline Industries, LP
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: 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.
Classification: Class II – may cause temporary or medically reversible health consequences
Recall date: May 4, 2026
Reported: Jun 24, 2026
Distribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Status: Ongoing
Quantity: 3521 units
Lot / codes: Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23FBQ975; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23FBF166; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23DBM780; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22KBM832; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22JBY524; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22GBR089; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22FBR153; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22FBC633; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22EBB478; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22BBX706; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22BBU902; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22ABN864; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 21IBO640; Medline Kit Number, SKU DYNJ908097A: UDI/DI
Company location: Northfield, IL
Recall type: Voluntary: Firm initiated
Recall number: Z-2508-2026
Agency: U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2508-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.