FDA recall Z-2281-2026

Product

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

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;

Key facts

Status

Ongoing

Initiation date

2026-04-15

Report date

2026-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2281-2026