Z-1236-2017Class III

Hidrex USA DP450

Name: Z-1236-2017 Hidrex USA DP450
Creator: Hidrex GmbH
Published: 2017-01-30
License: https://open.fda.gov/license/

Hidrex GmbH / initiated 2017-01-30 / Terminated / root cause: labeling and UDI

FDA source

Hidrex GmbH began a recall of Hidrex USA DP450 on 2017-01-30. FDA classified it as Class III and gives the reason as "The device was reclassified from a class III device to a class II device and there are new documentation requirements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1236-2017
Classification: Class III
Status: Terminated
Initiated: 2017-01-30
Posted: 2017-02-22
Terminated: 2017-08-04
Recalling firm: Hidrex GmbH
Product: Hidrex USA DP450
Product code: EGJ Device, Iontophoresis, Other Uses
Reason for recall: The device was reclassified from a class III device to a class II device and there are new documentation requirements.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Distributor sent recall notification letter to affected dealers and end users on 2/10/17. Notification letter will include a copy of the addendum to the user manual. The device is not instructed to be returned.
Quantity in commerce: 64 units
Distribution: Nationwide throughout the US
Product codes and lots: SN# 16-3.7091 to 16-3.7134, 17-3.7001 to 17-3.7020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1236-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1236-2017	Class III	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22
Z-1237-2017	Class III	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22
Z-1238-2017	Class III	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22

Product code EGJ

K133033Class IIHidrex Psp1000Hidrex GmbH / cleared 2015-04-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)