Western Oxytote DTE Digital VIPR System — Class II medical device recall Z-0270-2022
Ongoing recall by Western/Scott Fetzer Company, reported 2021-12-01, distributed in CT, MD, MT, OH. VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart w
| Recall number | Z-0270-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Western/Scott Fetzer Company, Westlake, OH, United States |
| Recall initiated | 2021-10-16 |
| Classified | 2021-11-19 |
| Reported by FDA | 2021-12-01 |
| Distributed | CT, MD, MT, OH |
| Quantity | 40 units |
| Reason classes | device malfunction |
| Model numbers | MNDS-603 |
Product
Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
Reason for recall
VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0270-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.