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MEDLINE Medical Procedure Kits labeled as recallZ-2508-2026 · Medline Industries, LP · initiated May 4, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers. For questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-2508-2026
Status
Open, Classified
Initiated by the company
May 4, 2026
Posted by the FDA
Jun 17, 2026
Recalling firm
Medline Industries, LP
Quantity
3521 units
Product code
OJH
Distribution
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (9k characters)

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 (each), 40889942886419 (case), Lot Number 21HMB506; Medline Kit Number, SKU DYNJ55637B: UDI/DI 10889942886418 (each), 40889942886419 (case), Lot Number 21CMB156; Medline Kit Number, SKU DYNJ55637B: UDI/DI 10889942886418 (each), 40889942886419 (case), Lot Number 21BMA535; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 26BBQ722; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25LBT225; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25JBV630; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25JBA301; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25GBG702; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25FBI032; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25EBV203; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25BBU777; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 24LBN665; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 24JBH892; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 24FBR472; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 24DBU491; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 24ABU986; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23JBH124; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23HBQ073; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23GBR436; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23FBS680; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23EBU086; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23BBK246; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22LBE875; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22JBD615; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22HBT661; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22GMH469; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22EMH976; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22AME279; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21LMD434; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21JMC555; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21JMB332; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21HMG155; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21GMC422; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21FMF742; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21EMF262; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21DMD509; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21AMC934; Medline Kit Number, SKU DYNJ67767: UDI/DI 10193489430615 (each), 40193489430616 (case), Lot Number 21ABW707; Medline Kit Number, SKU DYNJ67767: UDI/DI 10193489430615 (each), 40193489430616 (case), Lot Number 21ABM797; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 26ABL734; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 25ABO431; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 24LBH715; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 24KBB752; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 24JBJ191; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 24DBP178; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 24BBF170; Medline Kit Number, SKU DYNJV0172Q: UDI/DI 10193489336238 (each), 40193489336239 (case), Lot Number 21KBS950; Medline Kit Number, SKU DYNJ86229: UDI/DI 10195327604967 (each), 40195327604968 (case), Lot Number 24GMJ630; Medline Kit Number, SKU DYNJ86229: UDI/DI 10195327604967 (each), 40195327604968 (case), Lot Number 24CMG797.

Devices named in this recall

11 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 98994).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page