Electrosurgical Generator Coagulation Function May Fail During Surgery
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a documented functional defect in a surgical instrument. While no illnesses or injuries are reported in the source material, the hazard represents significant risk: failure of the coagulation function during surgery could prevent tissue coagulation and bleeding control, requiring emergency medical intervention. Per the rubric, risk-of-harm products with no reported injuries score at most 3 (High).
Plain-English summary
CooperSurgical, Inc. is recalling approximately 700 Quantum 2000 Electrosurgical Generators due to a defect in the hand switch coagulation function. The affected devices may fail to properly operate the coagulation function when the hand switch is used.
When the coagulation function fails to operate, the device cannot coagulate tissue during surgical procedures. This defect can result in prolonged surgical procedures and may require medical intervention to control intraoperative bleeding and allow the surgical case to be completed.
The recalled devices have been distributed throughout the United States and internationally to more than 30 countries including Canada, Mexico, China, India, Germany, and others. The recall applies to specific serial numbers that can be verified through the FDA recall notice.
The recalled product
- Product
- Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- coagulation-failure
- intraoperative-bleeding
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- ModerateMedela ENFit ExSet Enteral Extension Set Connector Compatibility Issue
FDA (Devices) · 2026-07-08
- ModerateProvena Midline Catheters recalled due to deficient manufacturing practices
FDA (Devices) · 2026-07-08
- ModeratePowerPICC Provena Catheters recalled for deficient manufacturing practices
FDA (Devices) · 2026-07-08
- ModerateCRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach
FDA (Devices) · 2026-07-08