PIE PAK Models: P2HC-A, P2HC-S, P2HC
- Company
- Edermy Llc
- Recall Initiated
- January 14, 2026
- Posted
- February 24, 2026
- Recall Number
- Z-1462-2026
- Quantity
- 11202 units
- Firm Location
- Pendergrass, GA
Reason for Recall
Lack of 510K clearance
Distribution
US Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.
Lot / Code Info
All Lots UDI:
Root Cause
No Marketing Application
Action Taken
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.