FDA Device recall Z-1482-2022
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
- FDA Device
- Class II
- completed
- Published 2022-08-10
On 2022-08-10 the FDA classified a Class II recall of PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10 by Aesculap Implant Systems, citing endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1482-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2020-04-01 |
| Published | 2022-08-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aesculap Implant Systems |
| Distribution | US |
Product
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Reason
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Identifiers
| code_info | UDI-DI: 04046955083381, lots M45171; M46651; M47463; M48124; M49436. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1482-2022%22
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