FDA DeviceClass IINotable

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

Date: 2026-06-10
Brand: Covidien, LP
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

2448 units

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