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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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.
These devices lack 510K clearance, which is necessary to ensure their safety and effectiveness. Using devices without this clearance poses a significant health risk to patients.
No specific incidents or injuries have been reported related to the recalled devices. The lack of clearance indicates potential risks that could affect patient health.
Patients and healthcare providers should stop using the devices immediately. Contact Edermy LLC or your healthcare provider for further instructions regarding the recall.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1462-2026 or contact Edermy LLC directly.
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