LEEP PRECISION Integrated System may fail to coagulate during surgery
CooperSurgical is recalling 75 units of the LEEP PRECISION Integrated System due to a defect where the hand switch may not activate the coagulation function, potentially causing prolonged surgery and bleeding complications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is an FDA Class II medical device recall affecting surgical equipment where the coagulation function may fail during procedures. While no illnesses or injuries have been reported, the potential for intraoperative bleeding complications requiring medical intervention represents a risk-of-harm scenario where injury has not yet been reported, justifying a High severity rating.
Plain-English summary
CooperSurgical, Inc. is recalling 75 units of the LEEP PRECISION Integrated System, 220V (part number LP-10-220). The recall covers devices with specific serial numbers manufactured between 2017 and 2021.
The device's coagulation function may not operate when the hand switch is used. If the device fails to coagulate tissue during a procedure, it may result in prolonged surgery and intraoperative bleeding, which would require medical intervention to control.
The affected devices were distributed nationwide throughout the United States and to 38 countries worldwide, including Canada, Mexico, the United Kingdom, Germany, China, India, and others.
The recalled product
- Product
- LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 75
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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