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U.S. Department of Health and Human Services

Class 2 Device Recall PIE

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 Class 2 Device Recall PIEsee related information
Date Initiated by FirmJanuary 14, 2026
Date PostedFebruary 24, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1461-2026
Recall Event ID 98303
Product Classification Colonic irrigation system - Product Code KPL
ProductPIE Trolley System Model: 2005
Code Information All Lots
FEI Number 1000511598
Recalling Firm/
Manufacturer		 Edermy LLC
115 Enterprise Dr Ste A
Pendergrass GA 30567-4701
Manufacturer Reason
for Recall		Lack of 510K clearance
FDA Determined
Cause 2		No Marketing Application
ActionOn 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.
Quantity in Commerce27 units
DistributionUS Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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