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FDA (Device enforcement)Recalled 2026-04-15class ii

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

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.

Details from the source

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: Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy; Quantity: 2448 units Lot/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;

UPC codes

10884521126732, 20884521126739, 10884521126787, 20884521126784

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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