Recall archive / FDA device enforcement
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600 — FDA record Z-0268-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 16, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class II
- Recalling firm
- Western/Scott Fetzer Company
- Quantity
- 4974 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0268-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
CT, MD, MT, OH
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 1, 2021
- Recall initiation date
- Oct 16, 2021
- Center classification date
- Nov 19, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.