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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 700
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · CooperSurgical, Inc.
See all →- SevereCooperSurgical Recalls Neonatal Nasal CPAP Replacement Sets Due to Loose Tubing
FDA (Devices) · 2026-09-30
- SevereCooperSurgical Recalls Infant Nasal CPAP Tubing Due to Loose Connection Risk
FDA (Devices) · 2026-09-30
- HighEndosee system convenience trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighHSG procedure trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighEndosee convenience kits label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
Same hazard · coagulation failure
See all →- HighLEEP PRECISION Surgical Generator May Fail to Coagulate During Surgery
FDA (Devices) · 2021-11-24
- HighLEEP PRECISION Electrosurgical System Coagulation Function May Fail
FDA (Devices) · 2021-11-24
- HighLEEP PRECISION Generator 120V Hand Switch Coagulation Function Failure
FDA (Devices) · 2021-11-24
- HighQuantum 2000 Electrosurgical Generator Hand Switch Coagulation Failure
FDA (Devices) · 2021-11-24
- HighLEEP PRECISION Integrated System may fail to coagulate during surgery
FDA (Devices) · 2021-11-24
Similar recalls
- HighCooperSurgical Recalls Quantum 2000 Electrosurgical Generators Due to Malfunction Risk
FDA (Devices) · 2019-12-11
- HighCooperSurgical Recalls Quantum 2000 Electrosurgical Generators Due to Malfunction
FDA (Devices) · 2019-12-11
- HighElectrosurgical Generators Olympus ESG-410 May Fail to Power On
FDA (Devices) · 2024-07-31
- HighElectrosurgical generators recalled over system error causing reboots during use
FDA (Devices) · 2025-08-27
- HighElectrosurgical Suction Coagulator Devices Recalled Due to Potential Suction Port Blockage
FDA (Devices) · 2022-12-21
- HighLegacy electrosurgical generators recalled over system error triggering repeated device reboots
FDA (Devices) · 2025-08-27