Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Pending LLM rewrite. Source: FDA_DEVICE Z-2281-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
- Manufacturer
- Covidien, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 1. Product Number: 170053
- UDI-DI: 10884521126732
- UPN: 20884521126739
- Lot number: J5L2332Y
- 2. Product Number: 170071
- UDI-DI: 10884521126787
- UPN: 20884521126784
- Lot number: J5H2924Y
Distribution
Distributed nationwide across the United States.
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