Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1840-2019·Announced 2019-06-26

LEEP Precision Integrated System Recalled for Incorrect Fuse Installation

CooperSurgical is recalling 19 LEEP Precision Integrated Systems because incorrect fuses may have been installed in the generator.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.

Plain-English summary

CooperSurgical, Inc. is recalling 19 units of the LEEP Precision Integrated System 120V, Model LP-10-120. The recall is due to the potential installation of 2.5A slow blow fuses in the LEEP Precision Generator instead of the appropriate 3.15A slow blow fuses.

The affected devices were distributed nationwide in California, Connecticut, Indiana, Massachusetts, Michigan, Minnesota, North Carolina, Nevada, New York, Ohio, Texas, Washington, and Wisconsin. The specific serial numbers for the affected units are 2018110001 through 2018110008, 2018110011 through 2018110017, and 2018110019 through 2018110022.

This is an FDA Class II recall. Users should contact CooperSurgical, Inc. for instructions on how to resolve the issue.

The recalled product

Product: LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures.…
Manufacturer: CooperSurgical, Inc.
Category: Medical Device — Surgical Equipment
Hazard: electrical-fault
Affected units: 19

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

2018110001
2018110002
2018110003
2018110004
2018110005
2018110006
2018110007
2018110008
2018110011
2018110012
2018110013
2018110014
2018110015
2018110016
2018110017
2018110019
2018110020
2018110021
& 2018110022

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Same manufacturer · CooperSurgical, Inc.

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Same hazard · electrical fault