Medline Industries, Lp: Ear, Nose, And Throat Surgical Tray
Recall Summary Medline is recalling several ear, nose, and throat surgical procedure kits distributed nationwide and internationally because sample units failed to meet quality standards. The issues identified include surface irregularities on catheters, connectors that detached prematurely from catheter funnels, and some catheters with incorrect outer diameters. This Class I recall affects medical facilities that received these kits across all U.S. states and multiple countries.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the 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 I
- 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/82869cbe-819b-4973-b07a-e74030fed973