FDAFDA · Food and drugs·Recall number Z-2497-2026

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

Published June 24, 2026 · Recall initiated: May 4, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer: Medline Industries, LP
Distributor: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Lot: 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
Risk classification: Class II
Area (FDA): device
Country: United States

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