FDAClass II · Medical device · Recalled June 10, 2026

Covidien EndoStitch" Polysorb Single Use Loading Unit recall — Covidien, LP

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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2281-2026
Brand: Covidien
Classification: Class II
Units affected: 2448 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Covidien EndoStitch" Polysorb Single Use Loading Unit

Companies & origin

Recalling firm location: North Haven, CT, United States
Firm address: 60 Middletown Ave, 06473-3908

Identifying details (verbatim from the notice)

Product codes / lots: 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: Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 98871
Recall initiated: April 15, 2026
FDA classified: June 1, 2026
FDA report date: June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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