FDA Device recall Z-0268-2022
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
- FDA Device
- Class II
- ongoing
- Published 2021-12-01
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-0268-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-16 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Western Scott Fetzer |
| Distribution | CT, 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
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