FDA Device recall Z-1461-2026
PIE Trolley System Model: 2005
- FDA Device
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of PIE Trolley System Model: 2005 by Edermy, citing lack of 510K clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1461-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-14 |
| Published | 2026-03-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Edermy |
| Distribution | US |
Product
PIE Trolley System Model: 2005
Reason
Lack of 510K clearance
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1461-2026%22
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