LEEP PRECISION Generator 120V Hand Switch Coagulation Function Failure
CooperSurgical is recalling 244 LEEP PRECISION Generator 120V units because the hand switch's coagulation function may fail to operate properly, potentially requiring medical intervention to control bleeding during surgical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a surgical device whose coagulation function may fail during procedures, potentially requiring medical intervention to control bleeding. However, no injuries or illnesses have been reported, making this a risk-of-harm product without reported incidents.
Plain-English summary
CooperSurgical, Inc. is recalling 244 units of the LEEP PRECISION Generator 120V (Part Number LP-20-120) with specific serial numbers spanning manufacturing dates from 2015 through 2021. The devices are distributed across the United States and 37 international locations including Canada, Mexico, and various countries throughout Europe, Asia, Africa, and the Caribbean.
The hand switch's coagulation function may fail to operate properly. When this function does not work as intended, surgical procedures may be prolonged and medical intervention may be required to control intraoperative bleeding to complete the case.
Facilities and healthcare providers using this equipment should identify affected units by serial number and contact CooperSurgical for further instructions. No patient injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- coagulation-failure
- bleeding-risk
- device-malfunction
Distribution
Distributed nationwide across the United States.
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