Reported Jun 24, 2026 · Ongoing
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents…
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)
- Lot codes and dates
291 of 291 products
Products covered by this recall Model / number Barcodes Product as published BIOB6861019348968402540193489684026Medline Kit Number/ : UDI/DI 10193489684025 (each), 40193489684026 (case), Lot Number 22CMD618 DYNJ832421019532724239840195327242399Medline Kit Number/ : UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23BBK690 DYNJ832421019532724239840195327242399Medline Kit Number/ : UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23ABK356 DYNJ832421019532724239840195327242399Medline Kit Number/ : UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23ABG037 DYNJ832421019532724239840195327242399Medline Kit Number/ : UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 22IBL708 DYNJ83242A1019532735072740195327350728Medline Kit Number/ : UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24GBK706 DYNJ83242A1019532735072740195327350728Medline Kit Number/ : UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24GBH415 DYNJ83242A1019532735072740195327350728Medline Kit Number/ : UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24FBQ282 DYNJ83242A1019532735072740195327350728Medline Kit Number/ : UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24FBC513 DYNJ83242A1019532735072740195327350728Medline Kit Number/ : UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23KBK097 DYNJ83242A1019532735072740195327350728Medline Kit Number/ : UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23DBF286 DYNJ83242A1019532735072740195327350728Medline Kit Number/ : UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23CBI425 DYNJ83242C1019845957565540198459575656Medline Kit Number/ : UDI/DI 10198459575655 (each), 40198459575656 (case), Lot Number 26DBE336 DYNJ67486A1019348988876840193489888769Medline Kit Number/ : UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 22ABR834 DYNJ67486A1019348988876840193489888769Medline Kit Number/ : UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 21HBL801 DYNJ67486A1019348988876840193489888769Medline Kit Number/ : UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 21FBK710 DYNJ14052D1088827753868940888277538680Medline Kit Number/ : UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 24ABS522 DYNJ14052D1088827753868940888277538680Medline Kit Number/ : UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 23HBB533 DYNJ14052D1088827753868940888277538680Medline Kit Number/ : UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 23BBD374 DYNJ14052D1088827753868940888277538680Medline Kit Number/ : UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 22HBN112 - Amount recalled
- 123030 units
This recall covers 64 products
The agency filed one notice per product. You are reading one of them; the other 63 are below.
51 more are in the archive.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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