# FDA recall Z-1376-2023

> **Western/Scott Fetzer Company** · Class II · device recall initiated 2023-01-03.

## 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.

## Distribution

US Nationwide distribution in the states of CO, CT, ID, MD, MT, TN, WA.

## Key facts

- **Recall number:** Z-1376-2023
- **Recalling firm:** Western/Scott Fetzer Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-03
- **Report date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westlake, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1376-2023

## Citation

> AI Analytics. FDA recall Z-1376-2023. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1376-2023. Source: US FDA. Licensed CC0.

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