FDA Device recall 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 p…

FDA Device
Class II
ongoing
Published 2026-06-24

On 2026-06-24 the FDA classified a Class II recall of MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of p… by Medline Industries, citing during an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfa….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2497-2026
Classification	Class II
Status	ongoing
Initiated	2026-05-04
Published	2026-06-24
Last updated	2026-09-13 11:58 UTC
Company	Medline Industries
Distribution	US

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.

Identifiers

code_info	Medline Kit Number/SKU BIOB686: UDI/DI 10193489684025 (each), 40193489684026 (case), Lot Number 22CMD618; Medline K… 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;

code_info

Medline Kit Number/SKU BIOB686: UDI/DI 10193489684025 (each), 40193489684026 (case), Lot Number 22CMD618; Medline K…

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;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2497-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.