Western/Scott Fetzer Company: Medical Device Recall in 2023 - (Recall #: Z-1376-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: January 3, 2023

Date Posted: April 19, 2023

Recall Number: Z-1376-2023

Event ID: 91561

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.

Status: Ongoing

Product Quantity: 24,287 units

Code Information:

ROC-9839, Roberts Oxygen Ready to Use Digital VIPR (head only) o UDI-DI: B929ROC98390 ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) o UDI-DI: B929ROC98400 MNDR-600, Western Oxytote DTE Digital VIPR (head only) o UDI-DI: B929MNDR6000 MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) o UDI-DI: B929MNDS6020 MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder) o UDI-DI: B929MNDS6030 All units distributed from 05/29/2020 to 12/7/2022.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated