FDA Device recall Z-0260-2022
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
- FDA Device
- Class II
- ongoing
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class II recall of LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220 by Coopersurgical, citing coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0260-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-29 |
| Published | 2021-11-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Reason
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
Identifiers
| code_info | Serial Numbers: 2018100001 2018100002 2018100003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0260-2022%22
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