RecallRadar

FDA Device recall Z-0268-2022

Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

On 2021-12-01 the FDA classified a Class II recall of Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600 by Western Scott Fetzer, citing VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0268-2022
ClassificationClass II
Statusongoing
Initiated2021-10-16
Published2021-12-01
Last updated2026-09-13 11:56 UTC
CompanyWestern Scott Fetzer
DistributionCT, MD, MT, OH

Product

Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

Reason

VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke

Identifiers

code_info
Units distributed from 05/29/20 to 08/31/21. Digital VIPR units manufactured and distributed after 08/31/21 are outsid…Units distributed from 05/29/20 to 08/31/21. Digital VIPR units manufactured and distributed after 08/31/21 are outside the scope of this recall and will be recognized by a green and silver control knob sticker (green logo, silver background)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0268-2022%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.