Reported Apr 19, 2023 · Ongoing

Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use…

Western/Scott Fetzer Company

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Western/Scott Fetzer Company · 875 Bassett Rd · Westlake, OH · 44145-1142

Is this the product you have?

  • 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)
Lot codes and dates
  • ROC-9839, Roberts Oxygen Ready to
  • Use Digital VIPR (head only) o UDI-DIB929ROC98390 ROC-9840, Roberts Oxygen Ready to Use Digital VIPR
  • System (with E-size cylinder) o UDI-DIB929ROC98400 MNDR-600, Western Oxytote
  • DTE Digital VIPR (head only) o UDI-DIB929MNDR6000 MNDS-602, Western Oxytote DTE Digital VIPR
  • System (with D-size cylinder) o UDI-DIB929MNDS6020 MNDS-603, Western Oxytote DTE Digital VIPR
  • System (with E-size cylinder) o UDI-DIB929MNDS6030 All units distributed from 05/29/2020 to 12/7/2022
Amount recalled
24,287 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

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