CooperSurgical recalls LEEP Precision Integrated System 120V and Generator models LP-10-120 and LP-20-120 due to potential failure of cut, coagulate, or blend functions when using the foot pedal.
The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.
CooperSurgical is recalling two medical devices: the LEEP Precision Integrated System 120V and LEEP Precision Generator models LP-10-120 and LP-20-120. The issue is that these devices may not function correctly when the foot pedal is used for cutting, coagulating, or blending procedures.
The foot pedal may not operate correctly with the cut, coagulate, or blend functions, which could lead to improper medical procedures. However, the recall does not indicate a risk of injury or serious harm in normal use.
Medical professionals who use these devices for procedures like cervical or uterine treatments may be affected. The risk is low as the hazard involves potential malfunction rather than immediate injury.
Check for model numbers LP-10-120 or LP-20-120 on the device. The lot/serial numbers listed in the recall include many combinations from 2015 to 2017.
Identify the model number on your device to see if it matches LP-10-120 or LP-20-120.
The foot pedal may not operate correctly with the cut, coagulate, or blend functions, potentially leading to improper medical procedures.
No, the recall does not require immediate discontinuation. The hazard is low risk and does not indicate a risk of injury or serious harm in normal use.
Check the model number on your device. Affected models are LP-10-120 and LP-20-120 with specific lot/serial numbers listed in the recall.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2057-2019 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-2057-2019 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
