FDAHealthApril 15, 2026
Covidien, LP — Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 15, 2026
Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
What's affected?
- Product
- Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
- Brand
- Covidien, LP
- Lot code
- J5L2332Y
Additional details
1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2448 units.
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