Covidien EndoStitch" Polysorb Single Use Loading Unit — Class II medical device recall Z-2281-2026
Ongoing recall by Covidien, LP, reported 2026-06-10, distributed nationwide. The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and pr
| Recall number | Z-2281-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2026-04-15 |
| Classified | 2026-06-01 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, DK, FR, IT |
| Quantity | 2,448 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10884521126732, 10884521126787, 20884521126739, 20884521126784 |
| Lot numbers | J5H2924Y, J5L2332Y |
Product
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2281-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.