RecallRadar

FDA Device recall Z-1236-2017

Hidrex USA DP450

On 2017-03-01 the FDA classified a Class III recall of Hidrex USA DP450 by Hidrex, citing the device was reclassified from a class III device to a class II device and there are new documentation requirements.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1236-2017
ClassificationClass III
Statusterminated
Initiated2017-01-30
Published2017-03-01
Last updated2026-09-13 11:54 UTC
CompanyHidrex
DistributionUS

Product

Hidrex USA DP450

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1236-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.