Quick Facts at a Glance
- Recall Date
- January 14, 2026
- Hazard Level
- HIGH
- Brand
- Edermy
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Edermy
- Product type
- Medical Device
- Model numbers
- All Lots UDI:
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 14, 2026
Reported by FDA DEVICE
March 4, 2026
RecallRadar source check
March 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of 510K clearance
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- Check if your device model is P2HC-A, P2HC-S, or P2HC.
- Refer to the recall documentation for specific identifiers related to your device.
- Contact Edermy LLC if you are unsure about your device's status.
Where to find product info
Look for model numbers on the device label or packaging to determine if it falls under the recall.
What timeline to expect
Expect a response from Edermy LLC regarding the recall process, though no specific timeline is provided.
If the manufacturer is unresponsive
- Document all communication attempts with Edermy LLC.
- Consider reporting the issue to the FDA or appropriate regulatory body if no response is received.
How to prevent similar issues
- Ensure that any medical devices you purchase have appropriate FDA clearance.
- Verify the brand and model against FDA recall lists before use.
- Consult with healthcare professionals about the safety of medical devices.
Documentation advice
Keep copies of your purchase receipt, any communication with the manufacturer, and notes on device use.
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Product Details
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.
Key Facts
- Recalled models: P2HC-A, P2HC-S, P2HC
- Total units recalled: 11,202
- Recall initiated on January 14, 2026
- Affected states include OH, AZ, IL, CA, and more
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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