⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Covidien, LP: Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

Medical DevicesSource: FDA (device) · Date: 2026-06-10

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Covidien, LP
Product
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
Recall initiated
2026-04-15
Code info
1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;
Product quantity
2448 units
Voluntary mandated
Voluntary: Firm initiated
City
North Haven
State
CT
Country
United States
Event id
98871
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