Medline Industries, Lp: General Surgery Tray
Consumer Summary Medline Industries is recalling certain medical procedure kits (including urological and surgical trays) distributed nationwide and internationally because sample testing found defects in the catheters included in these kits. The problems include rough catheter surfaces, connectors that detach prematurely, and catheters with incorrect outer diameters that don't meet specifications. This is a Class II recall, meaning there is a potential health risk, though the company has not reported any injuries or deaths related to these defects.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)
- 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/ad8a87fc-8625-459a-af7c-aeca714413d5