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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76362

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 30, 2017
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Hidrex GmbH

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Hidrex USA DP450

Z-1236-2017
Recall number
Z-1236-2017
Initiated
January 30, 2017
Classification
Class III
Status
Terminated
Recalling firm
Hidrex GmbH
Quantity
64 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device was reclassified from a class III device to a class II device and there are new documentation requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device was reclassified from a class III device to a class II device and there are new documentation requirements.

Code information

SN# 16-3.7091 to 16-3.7134, 17-3.7001 to 17-3.7020

Distribution pattern

Nationwide throughout the US

device · product 2 of 3

Hidrex USA DVP1000

Z-1237-2017
Recall number
Z-1237-2017
Initiated
January 30, 2017
Classification
Class III
Status
Terminated
Recalling firm
Hidrex GmbH
Quantity
180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device was reclassified from a class III device to a class II device and there are new documentation requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device was reclassified from a class III device to a class II device and there are new documentation requirements.

Code information

SN# 16-3.6190 to 16-3.6319, 17-3.6001 to 17-3.6050

Distribution pattern

Nationwide throughout the US

device · product 3 of 3

Daavlin Aquex (DAAV1000)

Z-1238-2017
Recall number
Z-1238-2017
Initiated
January 30, 2017
Classification
Class III
Status
Terminated
Recalling firm
Hidrex GmbH
Quantity
250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device was reclassified from a class III device to a class II device and there are new documentation requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device was reclassified from a class III device to a class II device and there are new documentation requirements.

Code information

SN# 16-3.8001 to 16-3.8250

Distribution pattern

Nationwide throughout the US