Recall Z-2281-2026
Covidien, LP · initiated April 15, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
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;
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2281-2026
- Initiated
- April 15, 2026
- Posted by FDA
- June 1, 2026
- Product code
- OCW – Endoscopic Tissue Approximation Device
- Quantity
- 2448 units
- Distribution
- Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
- Recalling firm
- Covidien, LP, North Haven, CT