Recall Z-1461-2026
Edermy LLC · initiated January 14, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PIE Trolley System Model: 2005
Codes / lots: All Lots
Reason for recall
Lack of 510K clearance
FDA-determined 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.
Details
- Recall number
- Z-1461-2026
- Initiated
- January 14, 2026
- Posted by FDA
- February 24, 2026
- Product code
- KPL – Colonic Irrigation System
- Quantity
- 27 units
- 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.
- Recalling firm
- Edermy LLC, Pendergrass, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1462-2026 Class II | PIE PAK Models: P2HC-A, P2HC-S, P2HCLack of 510K clearance | 01/14/2026Open, Classified |