FDA DevicesClass II
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 ...
Published: June 10, 2026Recall ID: Z-2281-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Affected Products
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Additional Source Details
| Field | Value |
|---|---|
| City | North Haven |
| State | CT |
| Event id | 98871 |
| Address 1 | 60 Middletown Ave |
| Code info | 1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y; |
| Postal code | 06473-3908 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 2448 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260415 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260601 |
Overview
- Recalling FirmCovidien, LP
- StatusOngoing
- Risk LevelClass II
- DistributionDomestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;