Covidien, LP recalls Covidien EndoStitch" Polysorb Single Use Loading Unit

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

On April 23, 2026 URGENT: VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Customer actions: - Immediately identify and quarantine all unused impacted product listed above. - See Appendix A for guidance on identifying affected lots. - This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Return all unused impacted product listed above to Medtronic. Medtronic Actions: - Medtronic representatives will assist customers with the return of affected product, upon request. - Medtronic representatives will work with customers to ensure replacement products are available to avoid interruptions in patient care.

• FDA enforcement recordOfficial FDA database entry for Z-2281-2026
• FDA 510(k) clearance · K934738The device's official FDA premarket clearance record
• FDA device classification · OCWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1500The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Covidien, LPSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.