Class II U.S. Food and Drug Administration

Medline Medical Procedure Kits labeled as Bioburden Test KIT 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

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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-2497-2026
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
123030 units
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit Number/SKU BIOB686: UDI/DI 10193489684025 (each), 40193489684026 (case), Lot Number 22CMD618; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23BBK690; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23ABK356; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23ABG037; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 22IBL708; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24GBK706; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24GBH415; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24FBQ282; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24FBC513; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23KBK097; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23DBF286; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23CBI425; Medline Kit Number/SKU DYNJ83242C: UDI/DI 10198459575655 (each), 40198459575656 (case), Lot Number 26DBE336; Medline Kit Number/SKU DYNJ67486A: UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 22ABR834; Medline Kit Number/SKU DYNJ67486A: UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 21HBL801; Medline Kit Number/SKU DYNJ67486A: UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 21FBK710; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 24ABS522; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 23HBB533; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 23BBD374; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 22HBN112; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 22OBA524; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 21JBN396; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 21ABG632; Medline Kit Number/SKU DYNJ14052F: UDI/DI 10195327659646 (each), 40195327659647 (case), Lot Number 25CBE701; Medline Kit Number/SKU DYNJ14052F: UDI/DI 10195327659646 (each), 40195327659647 (case), Lot Number 24HBD087; Medline Kit Number/SKU DYNJ14052F: UDI/DI 10195327659646 (each), 40195327659647 (case), Lot Number 24GBW446; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23JBH039; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23GBK315; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23FBF483; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23EBC641; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23CBF936; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23ABJ282; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 22HBL398; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 22GBI901; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 22FBB507; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 21LBT981; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (c…
UPC codes
10193489684025, 40193489684026, 10195327242398, 40195327242399, 10195327350727, 40195327350728, 10198459575655, 40198459575656, 10193489888768, 40193489888769, 10888277538689, 40888277538680, 10195327659646, 40195327659647, 10884389650059, 40884389650050

Products covered by this recall

MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)

Check your product

The notice names 44 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.

  • 10193489684025
  • 40193489684026
  • 10195327242398
  • 40195327242399
  • 10195327350727
  • 40195327350728
  • 10198459575655
  • 40198459575656
  • 10193489888768
  • 40193489888769
  • 10888277538689
  • 40888277538680
  • 10195327659646
  • 40195327659647
  • 10884389650059
  • 40884389650050

Lot or batch code

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

  • 22CMD618
  • 23BBK690
  • 23ABK356
  • 23ABG037
  • 22IBL708
  • 24GBK706
  • 24GBH415
  • 24FBQ282
  • 24FBC513
  • 23KBK097
  • 23DBF286
  • 23CBI425
  • 26DBE336
  • 22ABR834
  • 21HBL801
  • 21FBK710
  • 24ABS522
  • 23HBB533
  • 23BBD374
  • 22HBN112

Model or item number

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

  • BIOB686
  • DYNJ83242
  • DYNJ83242A
  • DYNJ83242C
  • DYNJ67486A
  • DYNJ14052D
  • DYNJ14052F
  • DYNJ14053D

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 — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  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.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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 10193489684025, 40193489684026, 10195327242398; lot code 22CMD618, 23BBK690, 23ABK356; model number BIOB686, DYNJ83242, DYNJ83242A. 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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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