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Open, Classified

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

FDA Recall Z-2281-2026 · Posted 2026-06-01

Recalling FirmCovidien, LP
Recall StatusOpen, Classified
Product CodeOCW
Date Initiated2026-04-15
Product Quantity2448 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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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