FDA Class II Quantum 2000 Electrosurgical Generators Voluntary Recall
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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II classification indicates a potentially serious issue, but the absence of any documented hazard details and no reported injuries, illnesses, or deaths in the source material result in a Moderate classification per the rubric for voluntary precautionary recalls.
Plain-English summary
CooperSurgical, Inc. is voluntarily recalling 154 units of Quantum 2000 Electrosurgical Generators (Part Number 909075-05W). The devices were distributed throughout the United States and to more than 40 foreign countries, including Canada, Mexico, China, Germany, India, and others.
The recall was classified as FDA Class II and was firm-initiated on September 29, 2021. The specific safety concern or defect that prompted the recall is not documented in the available source material. The recall remains ongoing.
Affected devices are identified by specific serial numbers including prefixes such as 0111, 0112, 0113, and others designated in the recall notice. Healthcare facilities and providers who have received these devices should contact CooperSurgical, Inc. in Trumbull, Connecticut, for further instructions regarding the recalled units.
The recalled product
- Product
- Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 154
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 →- HighHSG procedure trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighEndosee system convenience 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
- HighK-Systems Incubator Device Recall: Temperature May Exceed Desired Setting
FDA (Devices) · 2024-12-25
- HighK-Systems T47 Warming Plate may exceed desired temperatures
FDA (Devices) · 2024-12-25