Z-1461-2026Class II

PIE Trolley System Model: 2005

Name: Z-1461-2026 PIE Trolley System Model: 2005
Creator: Edermy LLC
Published: 2026-01-14
License: https://open.fda.gov/license/

Edermy LLC / initiated 2026-01-14 / Open, Classified

FDA source

Edermy LLC began a recall of PIE Trolley System Model: 2005 on 2026-01-14. FDA classified it as Class II and gives the reason as "Lack of 510K clearance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1461-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-14
Posted: 2026-02-24
Recalling firm: Edermy LLC
Product: PIE Trolley System Model: 2005
Product code: KPL Colonic Irrigation System
Reason for recall: Lack of 510K clearance
FDA 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 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 commerce: 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.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1461-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1461-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-24
Z-1462-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-24

Product code KPL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)