Skip to content
Recall Observatory FDA recall evidence

Device product

Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

Z-2281-2026

April 15, 2026

Class II

Product summary

Firm
Covidien, LP
Event
Event 98871
Status
Ongoing
Classification
Class II
Quantity
2448 units
Official record key
device-enforcement:Z-2281-2026

Official wording

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.

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;

Distribution pattern: Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.