Medline Industries, Lp: Catheter Care Tray
Summary Medline Industries is recalling a specific intermittent latex catheter product (16 Fr, 1000mL, model URO4RR16C) distributed nationwide and internationally because manufacturing defects were found during internal testing. The problems include surface irregularities, connectors that may detach prematurely, and outer diameter measurements that don't meet specifications. This is a Class II recall, affecting products distributed across the U.S. and multiple countries including Canada, the UAE, and others.
- Recalling firm
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-04
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4e0cb10d-1023-416c-8fbb-3f38ac3f75b4