Coapt ControlSeal Electrode Recalled Due to Burn and Blistering Risk
Coapt LLC is recalling 109 ControlSeal Electrodes due to risk of minor burns or blistering if exposed to direct sunlight or warm temperatures exceeding 12 hours, or if the battery is damaged.
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: The recall involves FDA Class II classification without reported hospitalizations or injuries. The hazard is minor burns or blistering under specific, conditional circumstances (>12 hours in direct sunlight or warm temperatures, or damaged battery). With no reported injuries and precautionary intent, this meets the criteria for a Moderate severity recall.
Plain-English summary
Coapt LLC is recalling the ControlSeal Electrode, a cutaneous EMG electrode. The recall affects 109 devices with worldwide distribution in the United States, Australia, Canada, and Sweden. The product identifier is UDI/DI: +B618P1/$+202210P1603, affecting all serial numbers.
The device may cause minor burns or blistering if exposed to direct sunlight and/or warm temperatures for over 12 hours, or if the battery is damaged. The FDA classified this as a Class II device recall.
Consumers with this device should contact Coapt LLC for information and guidance regarding the recall.
The recalled product
- Product
- Coapt ControlSeal Electrode, cutaneous EMG Electrode
- Manufacturer
- Coapt LLC
- Category
- Medical Device
- Hazard
- Affected units
- 109
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI: +B618P1/$+202210P1603
- All serial numbers
Distribution
Distributed nationwide across the United States.
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