Edermy LLC recalls PIE PAK Models: P2HC-A

Lack of 510K clearance

PIE PAK Models: P2HC-A, P2HC-S, P2HC

On January 14, 2026 PieMed issued a Urgent: Medical Device Recall Notification to affected consignees via mail. PieMed asked consignees to take the following actions: 1. Discontinue use of the PIE 2005 Trolley System and PIE PAK Components. 2. Secure and retain the PIE 2005 Trolley System and any unused PIE PAK kits in a controlled location to prevent further use. 3. Consult with a healthcare provider regarding continuation of care and alternative treatment options, as appropriate. 4. You may complete acknowledgement and receipt form in 2 weeks. 5. Please ensure this notification is provided to all affected individuals. If the device has been transferred to a different location, please ensure they are provided with a copy of the communication. 6. No further action should be taken with the affected device(s) unless directed by PIEMed.

• FDA enforcement recordOfficial FDA database entry for Z-1462-2026
• FDA device classification · KPLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5220The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Edermy LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.