HIGHFDA DEVICE

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

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.

Covidien, LPHealth & Personal CareMedical Devices1. Product Number: 170053UDI-DI: 10884521126732UPN: 20884521126739

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
April 15, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 15, 2026
Hazard Level
HIGH
Brand
Covidien, LP
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Covidien, LP
Model numbers
1. Product Number: 170053, UDI-DI: 10884521126732, UPN: 20884521126739, Lot number: J5L2332Y, 2. Product Number: 170071, UDI-DI: 10884521126787, UPN: 20884521126784, Lot number: J5H2924Y
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 15, 2026

  2. Reported by FDA DEVICE

    June 10, 2026

  3. RecallRadar source check

    June 16, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Covidien, LP or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Full Description

Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;. Reason: 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. Quantity: 2448 units. Distribution: Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
1. Product Number: 170053
UDI-DI: 10884521126732
UPN: 20884521126739
Lot number: J5L2332Y
2. Product Number: 170071
+3 more
Affected States
ALL
Report Date
June 10, 2026
Recall Status
ACTIVE