Edermy LLC recalled the PIE Trolley System Model 2005 on January 14, 2026 due to a lack of 510K clearance. The recall affects 27 units distributed nationwide across 15 states. Users must stop using the device and follow the manufacturer's instructions immediately.
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 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.
The lack of 510K clearance indicates that the device may not meet safety and efficacy standards set by the FDA. This high hazard level poses significant risks to patients and healthcare providers.
There are no reported incidents related to injuries or death associated with this recall. However, the lack of proper clearance is a serious concern for user safety.
Stop using the PIE Trolley System immediately. Contact Edermy LLC or your healthcare provider for further instructions.
For questions or to report issues, contact Edermy LLC via email at their official website or through the recall notice provided.
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