FDA Device recall Z-0257-2022
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
- FDA Device
- Class II
- ongoing
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class II recall of LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120 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-0257-2022 |
| 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 Integrated System, 120V CooperSurgical part number: LP-10-120
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: Lot/Serial Number 0115001 0115001 0115001 0115002 0115003 0115004 0115005 0115005 0115006…Serial Numbers: Lot/Serial Number 0115001 0115001 0115001 0115002 0115003 0115004 0115005 0115005 0115006 0115007 0115007 0115008 0115009 0115010 0115011 0115012 0115012 0115013 0115014 0115015 0115015 0115016 0115017 0115018 0115019 0115020 0115021 0115022 0115023 0115024 0115025 0115026 0115027 0115028 0115029 0115030 0115031 0115032 0115033 0115034 0115035 0115036 0115037 0115038 0115039 0115040 0215001 0215003 0215004 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0215012 0215013 0215014 0215015 0215016 0215017 0215018 0215019 0215019 0215020 0215021 1114001 1114002 1114003 1114004 1114005 1114006 1114007 1114008 1114009 1114010 1114011 1114012 1114013 1114013 1114014 1114015 1114016 1114017 1114018 1114019 1114020 1114021 1114022 1114023 1114024 1114025 1114026 1114027 1114028 1214001 1214002 1214003 1214004 1214005 1214005 1214006 1214007 2015060001 2015 |
|---|
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-0257-2022%22
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