Medline Industries, Lp: Catheter Care Tray
Recall Summary Medline Industries is recalling specific urethral catheterization trays (two product numbers, 15 French size) distributed nationwide and internationally because they don't meet quality standards. The issues include rough catheter surfaces, connectors that may detach prematurely from the catheter funnel, and some catheters with incorrect outer diameter measurements. This is a Class II recall, meaning there is potential for serious adverse health consequences.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.
- 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/cbe55e6c-e737-40da-b6a2-dcaa30162ad9