The Recall Desk
ModerateFDA (Devices)·Z-0263-2022·Announced 2021-11-24

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.
Category
Medical Device — Surgical Equipment

Distribution

Distributed nationwide across the United States.

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