Coapt LLC Coapt ControlSeal Electrode, cutaneous EMG Electrode Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Coapt ControlSeal Electrode, cutaneous EMG Electrode
Brand
Coapt LLC
Lot Codes / Batch Numbers
UDI/DI: +B618P1/$+202210P1603, All serial numbers
Products Sold
UDI/DI: +B618P1/$+202210P1603, All serial numbers
Coapt LLC is recalling Coapt ControlSeal Electrode, cutaneous EMG Electrode due to Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damag. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Recommended Action
Per FDA guidance
Coapt, LLC issued a Medical Device Correction notice to its consignees on 10/02/2023 via email. The notice explained the problem, risk, and urged users to take precautions as described in the most recent handbook: https://coaptengineering.com/clinicians. The handbook is under "Downloadable product handbooks."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026