Medline Industries, Lp: Gynecological Laparoscopic Kit
Recall Summary Medline Industries is recalling gynecological laparoscopic surgical kits distributed nationwide and internationally because some kits did not meet quality standards. The defects include surface irregularities on catheters, premature detachment of catheter connectors, and catheters with incorrect outer diameters. This is a Class II recall affecting multiple kit models used in gynecological procedures.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected 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/c2987ce6-2257-4b0e-8121-25d8a29a6e8f