Z-2281-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2026
- Initiation Date
- April 15, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2448 units
Product Description
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Reason for Recall
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
Distribution Pattern
Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
Code Information
1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;