PIE Trolley System Model: 2005 — Class II medical device recall Z-1461-2026
Ongoing recall by Edermy LLC, reported 2026-03-04, distributed nationwide. Lack of 510K clearance
| Recall number | Z-1461-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edermy LLC, Pendergrass, GA, United States |
| Recall initiated | 2026-01-14 |
| Classified | 2026-02-24 |
| Reported by FDA | 2026-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 27 units |
| Model numbers | 2005 |
Product
PIE Trolley System Model: 2005
Reason for recall
Lack of 510K clearance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1461-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.