FDA Device recall Z-1212-2019
Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a…
- FDA Device
- Class II
- terminated
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class II recall of Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a… by Covidien, citing sterilization method used was not consistent with the labeling and the approved sterilization method.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1212-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-13 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Covidien |
| Distribution | US |
Product
Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.
Reason
Sterilization method used was not consistent with the labeling and the approved sterilization method
Identifiers
| code_info | Lot Numbers: P8D1335PRX P8D1336PRX P8D1605PRX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1212-2019%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.