MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT — Class II medical device recall Z-2497-2026

Ongoing recall by Medline Industries, LP, reported 2026-06-24, distributed nationwide. During an internal review, Medline identified representative samples did not meet applicable performance speci

Recall number	`Z-2497-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Medline Industries, LP, Northfield, IL, United States
Recall initiated	2026-05-04
Classified	2026-06-17
Reported by FDA	2026-06-24
Distributed	Nationwide (US)
Quantity	123,030 units
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`10193489206067`, `10193489240092`, `10193489252347`, `10193489260458`, `10193489264951`, `10193489279597`, `10193489317459`, `10193489334074`, `10193489359060`, `10193489366358`, `10193489391046`, `10193489430950`, `10193489431858`, `10193489441376`, `10193489441406`, `10193489445657`, `10193489453942`, `10193489463460`, `10193489467697`, `10193489483253`, `10193489483260`, `10193489493856`, `10193489503739`, `10193489519662`, `10193489520828` and 475 more
Lot numbers	`20LDC279`, `20XBG601`, `20XBI088`, `21ABA331`, `21ABA383`, `21ABB264`, `21ABB910`, `21ABB911`, `21ABE277`, `21ABE351`, `21ABE433`, `21ABG632`, `21ABG735`, `21ABH318`, `21ABI172`, `21ABK144`, `21ABO841`, `21ABS836`, `21ABS968`, `21ABT468`, `21ABW348`, `21AKA700`, `21AMA964`, `21AMA977`, `21AMB808`, `21AMD339`, `21AME502`, `21AME661`, `21BBH695`, `21BBH856`, `21BBK514`, `21BBK825`, `21BBO165`, `21BBQ158`, `21BBR152`, `21BBR192`, `21BBR786`, `21BMA754`, `21BMD283`, `21BMD301` and 460 more

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 for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2497-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.