Class II U.S. Food and Drug Administration

Medline Medical Procedure Kits labeled as: KIT URO Robot Cystectomy 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-2506-2026
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
32438 units
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25HBR321; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25GBD202; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25FBK813; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25EBG207; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23FBK499; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23EBV071; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22KBK089; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22IBV707; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22HBC310; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26DMG168; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26CMD637; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25KMC849; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25JMA672; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25DMC189; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25CMH655; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25CMC735; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24KMA168; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24IMD969; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24GMF018; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24EMA387; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23LBR964; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23KBR832; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23JBE549; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21LME546; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21KMG048; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21JMH240; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21IMC541; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21GMD231; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21DME148; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21CMC690; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25HBB990; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25FBO533; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25EBA604; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25CBB580; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25ABE166; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24IBR571; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 4019532758…
UPC codes
10198459157028, 40198459157029, 10195327193454, 40195327193455, 10195327451653, 40195327451654, 10889942399239, 40889942399230, 10195327583781, 40195327583782

Products covered by this recall

MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)

Check your product

The notice names 35 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.

  • 10198459157028
  • 40198459157029
  • 10195327193454
  • 40195327193455
  • 10195327451653
  • 40195327451654
  • 10889942399239
  • 40889942399230
  • 10195327583781
  • 40195327583782

Lot or batch code

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

  • 25HBR321
  • 25GBD202
  • 25FBK813
  • 25EBG207
  • 23FBK499
  • 23EBV071
  • 22KBK089
  • 22IBV707
  • 22HBC310
  • 26DMG168
  • 26CMD637
  • 25KMC849
  • 25JMA672
  • 25DMC189
  • 25CMH655
  • 25CMC735
  • 24KMA168
  • 24IMD969
  • 24GMF018
  • 24EMA387

Model or item number

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

  • DYNJ83242B
  • DYNJ61059B
  • DYNJ61059C
  • DYNJT2135D
  • DYNJ51750C

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. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

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 10198459157028, 40198459157029, 10195327193454; lot code 25HBR321, 25GBD202, 25FBK813; model number DYNJ83242B, DYNJ61059B, DYNJ61059C. 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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