FDA (Devices) recall action 88648
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
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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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CooperSurgical is voluntarily recalling 154 Quantum 2000 Electrosurgical Generators under FDA Class II classification. The specific reason for recall is not documented in available source information.
CooperSurgical is recalling 75 units of the LEEP PRECISION Generator 220V because the coagulation hand switch may fail, potentially causing uncontrolled bleeding during surgery.
CooperSurgical's LEEP PRECISION System may fail to coagulate tissue when using the hand switch, potentially requiring medical intervention to control intraoperative bleeding during procedures.
CooperSurgical is recalling 244 LEEP PRECISION Generator 120V units because the hand switch's coagulation function may fail to operate properly, potentially requiring medical intervention to control bleeding during surgical procedures.
CooperSurgical recalled 700 Quantum 2000 Electrosurgical Generators due to a hand switch coagulation function defect that may fail to operate during surgery, potentially requiring medical intervention to control intraoperative bleeding.
CooperSurgical Quantum 2000 Electrosurgical Generators may fail to coagulate tissue when using the hand switch during surgery, potentially extending procedures and requiring medical intervention to control intraoperative bleeding. The Class II recall affects 193 units.
CooperSurgical is recalling 75 units of the LEEP PRECISION Integrated System due to a defect where the hand switch may not activate the coagulation function, potentially causing prolonged surgery and bleeding complications.