Medline Industries, Lp: Catheter Care Tray
Recall Summary Medline Industries is recalling Tonsil Pack Cath catheter care trays (Kit Number DYNJ65199A) that were distributed worldwide, including throughout the United States and several other countries. The catheters in these kits have manufacturing defects including surface finish irregularities, premature connector detachment, and diameter specifications that don't meet standards. This is classified as a Class II recall, meaning the products could cause temporary health problems or might fail to function properly.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A
- 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/b7fb619a-cd6e-4a25-bb6d-8bae4166687b