Endoscopic Tissue Approximation Device
Covidien EndoStitch Polysorb Single Use Loading Units (product numbers 170053 and 170071) are being recalled because holes in the packaging may allow the sterile product to be exposed to environmental contamination. This recall affects units distributed nationwide across the U.S. and in Austria, Canada, Denmark, France, and Italy.
- Product
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-15
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ec0c19a7-f945-4966-b06a-78e1036ba3b5