Recall Z-2281-2026 ยท OCW Endoscopic Tissue Approximation Device
Covidien, LP
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
| Date | Jun 1, 2026 (initiated Apr 15, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| 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, upo |
| Quantity | 2448 units |
| Distribution | Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934738 | AUTOSUTURE ENDOSCOPIC SUTURING DEVICE United States Surgical, A Division of Tyco Healthc, Mar 16, 1994 |