CLASS III Device recall · Reported 1 Mar 2017 · FDA Enforcement Report
Daavlin Aquex (DAAV1000) recalled by Hidrex
Hidrex is recalling Daavlin Aquex (DAAV1000), distributed nationwide in the US. The recall was initiated on 30 Jan 2017 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1238-2017
- FDA event ID
- 76362
- Recalling firm
- Hidrex, Heiligenhaus, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Jan 2017
- FDA classified
- 22 Feb 2017
- Reported
- 1 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Jan 2017 | Recall initiated by company | |
| 22 Feb 2017 | Classified by FDA | +23 days |
| 1 Mar 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
Product as listed by the FDA
Daavlin Aquex (DAAV1000)
Where it was distributed
Nationwide throughout the US
Questions about this recall
Is Daavlin Aquex (DAAV1000) recalled?
Yes. Hidrex recalled Daavlin Aquex (DAAV1000) on 30 Jan 2017. The recall is Class III and its status is Terminated. Recall number Z-1238-2017.
Why was it recalled?
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
Which lots are affected?
SN# 16-3.8001 to 16-3.8250
Where was it sold?
Nationwide throughout the US
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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