Medline Industries, Lp: Obstetrical Kit
Recall Summary Medline is recalling obstetrical and urological medical procedure kits distributed nationwide and internationally because sample testing found defects in catheters included in these kits, including surface irregularities, connectors that detach prematurely, and incorrect outer diameters that don't meet specifications. The affected kits have various names including "Kit Uro Robot Cystectomy," "D and C Pack," and others used in surgical procedures. This is a Class II recall, meaning the defective products could cause serious harm but are unlikely to cause death.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a 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 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/a6c4ba1d-c494-4113-8907-f6076b651791