FDA recall, , Moderate risk
Covidien EndoStitch Polysorb Single Use Loading Unit
The Covidien EndoStitch Polysorb Single Use Loading Unit may have holes in its pouch, compromising the sterile barrier.
Summary by Recall Canary from the FDA notice
What happened
Covidien, LP, of North Haven, Connecticut, is recalling the Covidien EndoStitch" Polysorb Single Use Loading Unit, product numbers 170053 and 170071, because holes in the pouch may compromise the package's ability to maintain the sterile barrier and protect the product from environmental exposure. The recall began April 15, 2026, and was added to the FDA's Enforcement Report on June 1, 2026.
The recalled units were distributed nationwide in the United States and internationally to Austria, Canada, Denmark, France, and Italy. The FDA classified the recall on June 1, 2026, and it was in the FDA's weekly enforcement report on June 10, 2026. A total of 2448 units are involved.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
- UDI-DI
- 10884521126732
- 20884521126739
- 10884521126787
- 20884521126784
- Lot code
- J5L2332Y
- J5H2924Y
Recall details
- Company began the recall
- Sold in
Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
- Company
- Covidien, LPNorth Haven, Connecticut
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98871
- Recall number
- Z-2281-2026
- Quantity recalled
- 2448 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
