CLASS II ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report
EndoStitch" Polysorb Single Use Loading Unit recalled by Covidien
Covidien is recalling EndoStitch" Polysorb Single Use Loading Unit, distributed nationwide in the US. The recall was initiated on 15 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2281-2026
- FDA event ID
- 98871
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Apr 2026
- FDA classified
- 1 Jun 2026
- Reported
- 10 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Apr 2026 | Recall initiated by company | |
| 1 Jun 2026 | Classified by FDA | +47 days |
| 10 Jun 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Where it was distributed
Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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 was it sold?
Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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