CooperSurgical recalls LEEP Precision Generator 120V (Part LP-20-120) due to risk of coagulation failure during use, potentially requiring medical intervention for bleeding. Affected units have specific serial numbers.
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
CooperSurgical is recalling its LEEP Precision Generator 120V devices (Part Number LP-20-120) because the coagulation function may fail when using the Hand Switch. This could lead to prolonged surgery and bleeding requiring medical intervention. Users should check if their device has the listed serial numbers.
The device's coagulation function may not work properly when the Hand Switch is used, which can cause bleeding during surgery. This might require medical staff to intervene to stop bleeding and complete the procedure, potentially prolonging surgery time.
Medical professionals using the LEEP Precision Generator 120V for procedures like cervical biopsies or other gynecological treatments. Those with the specific serial numbers listed in the recall are most at risk.
Check your device's serial number against the list provided in the recall. The affected units have specific serial numbers starting with patterns like 2015050001, 2016060030, and others listed in the recall notice.
Compare your device's serial number with the list of affected serial numbers provided in the recall.
The coagulation function may not operate correctly with the Hand Switch, which could lead to bleeding during procedures requiring medical intervention.
Check your device's serial number against the list of affected serial numbers provided in the recall. If it's listed, you should stop using it and contact CooperSurgical for further instructions.
The recall record does not specify a remedy, so no fix is provided. Affected users should stop using the device and contact CooperSurgical for guidance.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0259-2022 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-0259-2022 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.
