Class III — Hidrex GmbH
| Recalling firm | Hidrex GmbH |
|---|---|
| Registered facility | HIDREX GMBH (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The device was reclassified from a class III device to a class II device and there are new documentation requirements. |
| Product | Hidrex USA DP450 |
| Quantity | 64 units |
| Distribution | Nationwide throughout the US |
| Initiated | 2017-01-30 |
| Classified | 2017-02-22 |
| Terminated | 2017-08-04 |
| Recall number | Z-1236-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Hidrex GmbH (Z-1236-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76362/
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