Recall Z-1461-2026 ยท KPL Colonic Irrigation System
Edermy LLC
PIE Trolley System Model: 2005
| Date | Feb 24, 2026 (initiated Jan 14, 2026) |
| Status | Open, Classified |
| Reason | Lack of 510K clearance |
| Root cause | No Marketing Application |
| Action | 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 prov |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.