Recall Z-1322-2022 ยท GAG Stapler, Surgical
Covidien, LP
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
| Date | May 13, 2022 |
| Status | Open, Classified |
| Reason | The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples. |
| Root cause | Process change control |
| Action | Beginning 13-MAY-2022 communications to all affected consignees began. In the United States notifications are set via UPS 2-day delivery. Customers should return all unused affected product in inventory to Medtronic. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been transferred. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification. |
| Quantity | 433,560 |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.