FDA Device recall Z-0009-2021
Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The E…
- FDA Device
- Class II
- ongoing
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The E… by Covidien, citing the device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0009-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-08-12 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Covidien |
| Distribution | US |
Product
Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Reason
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Identifiers
| code_info | Lot Numbers: 00Z2117 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0009-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.