Class II U.S. Food and Drug Administration

Medline Medical Procedure Kits labeled as Basic GYN, CW LAP GYN 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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-2503-2026
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
44656 units
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24GMJ742; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24FMC978; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24CMA556; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24BMI027; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24AMF247; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24AMA807; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23IMF051; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23HMG141; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23EMF259; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23DMA689; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23CMF097; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23CMC699; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22LME333; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22KMB390; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22HMC449; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22GMD678; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22FMG214; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22DME100; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22CME928; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22BMG698; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22AMD289; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21KMD167; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21JMF926; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21IMD987; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21GME755; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21FBF900; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21CBF873; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21ABE015; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 26DME629; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25LMG110; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25LMB085; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25IMH993; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25EMC711; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25DMH514; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25CMD890; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25CMB602; Medline Kit Number/SKU DYNJ905924C: UDI…
UPC codes
10193489773484, 40193489773485, 10198459256400, 40198459256401

Products covered by this recall

MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)

Check your product

The notice names 27 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.

  • 10193489773484
  • 40193489773485
  • 10198459256400
  • 40198459256401

Lot or batch code

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

  • 24GMJ742
  • 24FMC978
  • 24CMA556
  • 24BMI027
  • 24AMF247
  • 24AMA807
  • 23IMF051
  • 23HMG141
  • 23EMF259
  • 23DMA689
  • 23CMF097
  • 23CMC699
  • 22LME333
  • 22KMB390
  • 22HMC449
  • 22GMD678
  • 22FMG214
  • 22DME100
  • 22CME928
  • 22BMG698

Model or item number

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

  • DYNJ905924B
  • DYNJ905924D
  • DYNJ905924C

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  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.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 10193489773484, 40193489773485, 10198459256400; lot code 24GMJ742, 24FMC978, 24CMA556; model number DYNJ905924B, DYNJ905924D, DYNJ905924C. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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