Medline Industries, Lp: Pelvic Exam Kit
Pelvic Exam Kit Recall Summary Medline is recalling its PELVIC LAP PACK (Kit Number DYNJ53820B) because testing found defects in the catheter component, including surface irregularities, connectors that detach prematurely, and incorrect outer diameter measurements. The kits were distributed nationwide across the U.S. and internationally to several countries. This is classified as a Class II recall, indicating a potential health risk.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
- 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/1da5749d-6809-4b16-adaa-f40f2eb020a1