Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
FDA Recall Z-2281-2026 · Posted 2026-06-01
Advertisement
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.
Advertisement