Coapt LLC is recalling 109 units of the Coapt ControlSeal Electrode, a cutaneous EMG electrode used in medical device systems. The recall was initiated because the device can overheat if exposed to direct sunlight or warm temperatures for more than 12 hours, or if the battery is damaged. This overheating can lead to skin injuries for the patient wearing the device. Consumers should identify these devices by checking for the UDI/DI code +B618P1/$+202210P1603 and contact their healthcare provider or the manufacturer for instructions.
If the electrode is exposed to heat or sunlight for an extended period, or if its battery is compromised, the device may overheat against the user's skin. This can cause the patient to experience minor burns or blistering at the site of contact.
manufacturer or healthcare provider Consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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