Edermy LLC recalled 11,202 medical devices on January 14, 2026. The recall affects models P2HC-A, P2HC-S, and P2HC due to lack of proper FDA clearance. Patients and healthcare providers should immediately cease use of these devices and follow recall instructions.
Lack of 510K clearance
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Edermy LLC or your healthcare provider for instructions. Notification method: E-Mail
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These devices are used in various health monitoring applications. Consumers typically buy them for personal or professional medical use, relying on their effectiveness for health management.
The lack of 510K clearance indicates the devices have not undergone the necessary FDA evaluation to confirm their safety and efficacy. This absence raises serious concerns about their reliability and potential health risks.
This recall is not part of a broader industry pattern.
Consumers must stop using these devices immediately, as doing so could lead to undetected health issues. The urgency to act is high due to the potential risks involved.
Look for model numbers on the device label or packaging to determine if it falls under the recall.
Expect a response from Edermy LLC regarding the recall process, though no specific timeline is provided.
Keep copies of your purchase receipt, any communication with the manufacturer, and notes on device use.
The recalled models include P2HC-A, P2HC-S, and P2HC. These devices were distributed nationwide, including states such as Ohio, Arizona, Illinois, and California. The quantity recalled is 11,202 units.
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