Is Hidrex USA DP450 recalled?

The device was reclassified from a class III device to a class II device and there are new documentation requirements. Status: Voluntary: Firm initiated Initial Firm Notification: Letter Distribution: Nationwide throughout the US

Low RiskFDA Device

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

Agency Publication Date: February 22, 2017

Affected Products

Product: Hidrex USA DP450

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

Product: Hidrex USA DVP1000

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

Product: Daavlin Aquex (DAAV1000)

SN# 16-3.8001 to 16-3.8250

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76362

Status: Resolved

Manufacturer: Hidrex GmbH

Manufactured In: Germany

Units Affected: 3 products (64 units; 180 units; 250 units)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.