CooperSurgical recalls LEEP Precision Integrated System (120V, part number LP-10-120) due to potential failure of coagulate function with Hand Switch, which may lead to prolonged surgical procedures requiring medical intervention for bleeding control.
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 Integrated System (120V, part number LP-10-120) because the coagulate function may not work properly when using the Hand Switch. This could cause bleeding during procedures that requires medical intervention to stop. Affected units have specific serial numbers listed in the recall.
The coagulate function may not operate correctly when the Hand Switch is used, leading to bleeding that cannot be controlled during surgery. This could require medical intervention to stop bleeding and complete the procedure, potentially prolonging surgery time.
Medical professionals using the LEEP Precision system for procedures involving tissue removal. Patients undergoing procedures with this device may be at risk if the coagulate function fails during surgery.
Check if your LEEP Precision Integrated System (120V, part number LP-10-120) has a serial number listed in the provided range (e.g., 0115001 to 2021060028).
Verify if your device has a serial number from the list provided in the recall (e.g., 0115001 to 2021060028).
Reach out to CooperSurgical directly for further assistance or to confirm if your device is affected.
The LEEP Precision system is used for medical procedures involving tissue removal, such as cervical procedures.
No, but you should check if your device is affected by the recall and contact CooperSurgical for guidance.
Check your device's serial number against the list provided in the recall (e.g., 0115001 to 2021060028).
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0257-2022 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-0257-2022 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.
