Covidien EndoStitch" Polysorb Single Use Loading Unit recall (Covidien, LP)
Medical deviceClass IIOngoing
Summary: Covidien, LP is recalling Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;. Reason: 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.
What is being recalled
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
How to tell if yours is affected
1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2281-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 15, 2026 |
| Reported | June 10, 2026 |
| Company | Covidien, LP |
| Company location | North Haven, CT, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2448 units |
More recalls from Covidien, LP · all medical device recalls · recalls from April 2026