Westlake, OH, United States
Western/Scott Fetzer Company recalls
2 recalls recorded since 2018, most recently on 3 January 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 January 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1376-2023
- 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) MND
Ongoing Class II Medical devices
- Recall started
- 16 October 2021
- Reason
- VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
- Distribution
- CT, MD, MT, OH
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0269-2022, Z-0270-2022, Z-0268-2022, Z-0267-2022
- Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
- Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
- Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
- Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.