MEDLINE Urethral Catheterization Tray and Bag: recall status
Notice names this product. Medline Industries’s MEDLINE Urethral Catheterization Tray and Bag is named in FDA Class II recall Z-2482-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported 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. Identifying details: UDI/DI 10080196996759 (each), 40080196996750 (case); ALL LOTS. Units affected: 235658 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
MEDLINE Urethral Catheterization Tray and Bag
Company / brand
Medline Industries
Lot / serial / date codes
UDI/DI 10080196996759 (each), 40080196996750 (case); ALL LOTS
Distribution
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Agency product description and boundaries
MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…