---
title: "PIE Trolley System Model: 2005 — FDA record Z-1461-2026 | Is It on Recall"
description: "Lack of 510K clearance"
url: https://isitonrecall.com/recall/fda-device-z-1461-2026-pie-trolley-system-model-2005/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# PIE Trolley System Model: 2005 — FDA record Z-1461-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 14, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: PIE Trolley System Model: 2005
- **Reason**: Lack of 510K clearance
- **Classification**: Class II
- **Recalling firm**: Edermy LLC
- **Quantity**: 27 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1461-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1461-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | All Lots |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

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## Dates in the source

- **Report date**: Mar 4, 2026
- **Recall initiation date**: Jan 14, 2026
- **Center classification date**: Feb 24, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1461-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Edermy LLC records](https://isitonrecall.com/brand/edermy-llc/)