Class II U.S. Food and Drug Administration

Medline Medical Procedure Kits labeled as: 1) Crani recall: During an internal review, Medline identified representative samples did

Recall published 4 months ago

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.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2508-2026
Published
June 24, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
3521 units
Distribution
Nationwide
Made in
United States
Lot / code info
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…
UPC codes
10193489973846, 40193489973847, 10195327507077, 40195327507078, 10198459043499, 40198459043490, 10198459129773, 40198459129774, 10198459237782, 40198459237783, 10198459600197, 40198459600198, 10889942886418, 40889942886419

Products covered by this recall

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.

Check your product

The notice names 46 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10193489973846
  • 40193489973847
  • 10195327507077
  • 40195327507078
  • 10198459043499
  • 40198459043490
  • 10198459129773
  • 40198459129774
  • 10198459237782
  • 40198459237783
  • 10198459600197
  • 40198459600198
  • 10889942886418
  • 40889942886419

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 23FBQ975
  • 23FBF166
  • 23DBM780
  • 22KBM832
  • 22JBY524
  • 22GBR089
  • 22FBR153
  • 22FBC633
  • 22EBB478
  • 22BBX706
  • 22BBU902
  • 22ABN864
  • 21IBO640
  • 24EBC216
  • 24CBU878
  • 23LBV779
  • 23JBV724
  • 23JBQ243
  • 23JBQ188
  • 23IBS778

Model or item number

On the rating label, the box or the instruction sheet.

  • DYNJ908097
  • DYNJ908097A
  • DYNJ908097B
  • DYNJ908097C
  • DYNJ908097D
  • DYNJ912029
  • DYNJ55637B
  • DYNJ43930A
  • DYNJ67767
  • DYNJ61136F
  • DYNJV0172Q
  • SKU DYNJ908097

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices 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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10193489973846, 40193489973847, 10195327507077; lot code 23FBQ975, 23FBF166, 23DBM780; model number DYNJ908097, DYNJ908097A, DYNJ908097B. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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