FDAFDA · Food and drugs·Recall number Z-2281-2026
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Published June 10, 2026 · Recall initiated: April 15, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Covidien, LP
- Distributor
- Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
- Lot
- 1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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