Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR — Class II medical device recall Z-1376-2023
Ongoing recall by Western/Scott Fetzer Company, reported 2023-04-19, distributed nationwide. Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual ta
| Recall number | Z-1376-2023 |
|---|---|
| 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 | 2023-01-03 |
| Classified | 2023-04-12 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 24,287 units |
| Reason classes | device malfunction |
Product
Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)
Reason for recall
Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use without audible alarms, potentially leading to an out of oxygen event and no flow.
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-1376-2023. 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.