FDAClass II · Medical device · Recall Z-2281-2026 · Recalled June 10, 2026

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

Agency report date: June 10, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Covidien EndoStitch" Polysorb Single Use Loading Unit
Company / brand: Covidien
Lot / serial / date codes: 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;

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

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

Affected product: Covidien EndoStitch" Polysorb Single Use Loading Unit

3. Open the official notice or contact

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

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

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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