FDA (Devices) recall action 76362
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Hidrex GmbH is recalling 180 units of the Hidrex USA DVP1000 device because it was reclassified from Class III to Class II, triggering new documentation requirements.
Hidrex GmbH is recalling 250 Daavlin Aquex (DAAV1000) devices nationwide because the device was reclassified from Class III to Class II, triggering new documentation requirements.
Hidrex GmbH is recalling 64 units of the Hidrex USA DP450 device because it was reclassified from Class III to Class II, triggering new documentation requirements.