Medline Industries, Lp: Angiography/angioplasty Kit
Recall Summary Medline is recalling laparoscopy combined procedure kits (SKU DYNJ37378A) distributed worldwide because some samples failed quality specifications. The issues include irregular catheter surface finish, premature detachment of the catheter connector, and some catheters with outer diameters that didn't meet specifications. The kits were distributed across all U.S. states and several countries including Canada, the Netherlands, and others.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A
- 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/692b8ae0-a5c7-42ca-b343-b4d389125f6b