FDA Device recall Z-1238-2017
Daavlin Aquex (DAAV1000)
- FDA Device
- Class III
- terminated
- Published 2017-03-01
On 2017-03-01 the FDA classified a Class III recall of Daavlin Aquex (DAAV1000) by Hidrex, citing the device was reclassified from a class III device to a class II device and there are new documentation requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1238-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-01-30 |
| Published | 2017-03-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hidrex |
| Distribution | US |
Product
Daavlin Aquex (DAAV1000)
Reason
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
Identifiers
| code_info | SN# 16-3.8001 to 16-3.8250 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1238-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.