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
- Trolley System
- Model numbers
- All Lots
- 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
The PIE Trolley System Model 2005 is a medical device used in healthcare settings to assist in patient transportation. It provides mobility support for healthcare professionals during patient transfers.
Why This Is Dangerous
The lack of 510K clearance means that the PIE Trolley System has not been evaluated by the FDA for safety and effectiveness, which can lead to potential risks during use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may inconvenience healthcare providers who rely on this equipment for patient transport, potentially affecting patient care and safety.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device to see if it is Model 2005.
- Confirm if you purchased the device within the recall period.
- Look for any communications from Edermy LLC regarding the recall.
Where to find product info
The model number and serial number can typically be found on the device's label or in the user manual.
What timeline to expect
Expect a processing time of 4-8 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Continue to follow up with Edermy LLC via email.
- Document all communications and attempts to reach the company.
How to prevent similar issues
- Always check for FDA clearance before purchasing medical devices.
- Seek alternatives that have been evaluated for safety and efficacy.
- Stay informed about recalls in the healthcare industry.
Documentation advice
Keep records of your purchase, communications with the manufacturer, and any relevant photos of the product.
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Product Details
The PIE Trolley System Model 2005 has been recalled due to regulatory issues. A total of 27 units were distributed nationwide in states including California, Texas, and New York.
Key Facts
- 27 units recalled nationwide
- Affected model: PIE Trolley System Model 2005
- Lack of 510K clearance poses serious risk
- Stop using the device immediately
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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