CooperSurgical LEEP Precision System Foot Pedal Function Defect Recall
CooperSurgical is recalling LEEP Precision Integrated Systems because the foot pedal may fail to operate the cut, coagulate, or blend functions.
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: The recall is classified as FDA Class II, and the hazard involves a medical device that may fail to perform essential functions during a procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
CooperSurgical, Inc. is recalling 358 units of the LEEP Precision Integrated System 120V and LEEP Precision Generator, Model Nos. LP-10-120 and LP-20-120. The recall was initiated because the products' cut, coagulate, or blend function may not operate when the Foot Pedal is used.
The affected devices were distributed domestically across the United States, as well as internationally to Canada and Costa Rica. The recall covers specific lot and serial numbers listed in the official FDA notice.
Healthcare providers and consumers should stop using the affected devices and contact CooperSurgical, Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 358
Distribution
Distributed nationwide across the United States.
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