The Recall Desk
Agency classClass IIOur severity: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.

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 2/5 (Moderate).

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
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 →

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