FDA Medical devices recall ·
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT… recall
- Recall number
- Z-2497-2026
- Date
- (initiated May 4, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 123030 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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), Lo
Distribution
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
States: California Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2497-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.