Medline Industries, Lp: Laparoscopy Kit
Recall Summary Medline Industries is recalling four laparoscopy surgical kits with specific product numbers (DYNJ0656274AC, DYNJ0656274AB, DYNJ35312I, and DYNJ0656274AA) distributed nationwide. The cannula components in these kits don't meet required dimensional standards and may leak or break during surgical use. This Class II recall affects hospitals and surgical facilities across all U.S. states.
- Recalling firm
- Medline Industries, LP
- Product
- Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AB; 3) CATH LAB ENDO AAA, Medline product number/SKU DYNJ35312I; 4) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AA.
- Reason
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-02
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/49398592-0d78-4444-9109-3dabc11f14a6