Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Summary
The FDA issued a Class II for Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 by Covidien, LP. 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 ex.
Details
Source
Device Recall
External ID
Z-2281-2026
Action Date
2026-06-10
Status
Ongoing
Category
device
Product Description
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Lot/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;
Quantity Affected: 2448 units
Reason for Recall
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.
Distribution
Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-15
Company
North Haven, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 169 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien, LP has 89 FDA actions in our database, including 89 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien, LP have FDA actions?
Covidien, LP has 89 FDA actions in our database, including 89 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2281-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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