Medline Industries, LP recalls MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag
- Recalling company
- Medline Industries, LP
- Product
- MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 4, 2026
- Reported
- Jun 24, 2026
- Distribution
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
- Status
- Ongoing
- Quantity
- 10980 units
- Lot / codes
- UDI/DI 10197344149001 (each), 20197344149008 (case); ALL LOTS
- Company location
- Northfield, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2484-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2484-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.