FDAFDA · Food and drugs·Recall number Z-2508-2026

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.

Published June 24, 2026 · Recall initiated: May 4, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer: Medline Industries, LP
Distributor: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Lot: 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 10195327507077 (each), 40195327507078 (case), Lot Number 24EBC216; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 24CBU878; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 23LBV779; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 23JBV724; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 23JBQ243; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 23JBQ188; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 23IBS778; Medline Kit Number, SKU DYNJ908097B: UDI/DI 10198459043499 (each), 40198459043490 (case), Lot Number 24IBU230; Medline Kit Number, SKU DYNJ908097B: UDI/DI 10198459043499 (each), 40198459043490 (case), Lot Number 24HBF200; Medline Kit Number, SKU DYNJ908097B: UDI/DI 10198459043499 (each), 40198459043490 (case), Lot Number 24GBJ113; Medline Kit Number, SKU DYNJ908097B: UDI/DI 10198459043499 (each), 40198459043490 (case), Lot Number 24GBB611; Medline Kit Number, SKU DYNJ908097C: UDI/DI 10198459129773 (each), 40198459129774 (case), Lot Number 24LBI207; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 26BBN470; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25LBO007; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25KBT991; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25EBW026; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25EBA043; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25EBA044; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25CBG395; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25CBC209; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25BBH141; Medline Kit Number, SKU DYNJ912029: UDI/DI 10198459600197 (each), 40198459600198 (case), Lot Number 26ABG299; Medline Kit Number, SKU DYNJ55637B: UDI/DI 10889942886418
Risk classification: Class II
Area (FDA): device
Country: United States

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