Home/Recalls/FDA-Z-2281-2026
FDA DevicesClass II

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

Published: June 10, 2026Recall ID: Z-2281-2026Category: devicesCountry: US
US
Medical DeviceFDA DevicesUSUS

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

Recalling Firm: Covidien, LP

Reason for Recall / 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.

Product Description & Identification

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

Affected Products

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

Additional Source Details

FieldValue
CityNorth Haven
StateCT
Event id98871
Address 160 Middletown Ave
Code info1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;
Postal code06473-3908
Report date20260610
Product typeDevices
Product quantity2448 units
Reason for recallThe presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260415
Initial firm notificationTwo or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date20260601

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Overview

  • Recalling FirmCovidien, LP
  • StatusOngoing
  • Risk LevelClass II
  • DistributionDomestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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

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https://therecallfile.com/recalls/covidien-endostitch-polysorb-single-use-loading-unit-product-numbers-1/FDA-Z-2281-2026
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