The Recall Desk

FDA (Devices) recall action 88877

Western/Scott Fetzer Company recalled 4 products on 2021-12-01

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2021-12-01
Critical
0
Units
16,395

Why these products were recalled

VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2021-12-01

    Western Digital VIPR Medical Device Recalled for Battery Rupture Risk

    Western/Scott Fetzer is recalling Digital VIPR devices (Model MNDR-600) due to battery rupture risk that could cause plastic shroud breakage and fume emission. The recall affects 4974 units distributed from May 2020 to August 2021.

    Product
    Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2021-12-01

    Western Oxytote VIPR System Battery Rupture Risk with Fume Emission

    Western/Scott Fetzer Company is recalling 40 units of the Western Oxytote DTE Digital VIPR System due to battery rupture risk that can break the plastic shroud and release fumes and smoke.

    Product
    Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2021-12-01

    Roberts Digital VIPR System Battery Rupture Risk Recall

    Western/Scott Fetzer Company is recalling 11,341 Roberts Digital VIPR System units distributed to Connecticut, Maryland, Montana, and Ohio due to battery rupture risk that could cause the plastic shroud to break apart and emit fumes and smoke.

    Product
    Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2021-12-01

    FDA Recalls Western Oxytote DTE Digital VIPR System Due to Battery Rupture Risk

    Western/Scott Fetzer Company is recalling 40 units of the Oxytote DTE Digital VIPR System due to battery rupture risk. The device may emit fumes and smoke when the battery ruptures and plastic shroud breaks apart.

    Product
    Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
    Category
    Distribution
    4 states