Medline Industries, Lp: Catheter Care Tray
Recall Summary Medline is recalling specific batches of Intermittent Latex Catheter Coude Pre-Connected to Collection Bag (14 Fr, 1000mL) because samples failed quality testing. The issues include surface irregularities on the catheter, connectors that may detach prematurely, and some catheters that don't meet size specifications. The product was distributed nationwide in the US and internationally to multiple countries.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C
- 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/abcc1897-f768-4b4e-93bc-3d0e383161fc