Official recall notice
FDA DeviceClass IINotable
FDA Recall: Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
- Recall date
- 2026-06-10
- Brand
- Covidien, LP
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
2448 units
Product 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.