CLASS II · ModerateFDA

Medline Industries, LP recalls MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT

📅 May 4, 2026 · 📍 Nationwide

Recalling company: Medline Industries, LP
Product: MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)
Reason: 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.
Classification: Class II – may cause temporary or medically reversible health consequences
Recall date: May 4, 2026
Reported: Jun 24, 2026
Distribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Status: Ongoing
Quantity: 123030 units
Lot / codes: 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 1019348
Company location: Northfield, IL
Recall type: Voluntary: Firm initiated
Recall number: Z-2497-2026
Agency: U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2497-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.