🔍 RecallPedia

Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

Class I - Dangerous
🏥 Medical Devices Recalled: October 16, 2021 Western/Scott Fetzer Company Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Units distributed from 05/29/20 to 08/31/21. Digital VIPR units manufactured and distributed after 08/31/21 are outside the scope of this recall and will be recognized by a green and silver control knob sticker (green logo, silver background)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Western/Scott Fetzer Company
Reason for Recall:
VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

Product Codes/Lot Numbers:

Units distributed from 05/29/20 to 08/31/21. Digital VIPR units manufactured and distributed after 08/31/21 are outside the scope of this recall and will be recognized by a green and silver control knob sticker (green logo, silver background)

Distribution:

Distributed in: CT, MD, MT, OH

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0268-2022

Related Recalls

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)

Western/Scott Fetzer Company

Class I - Dangerous

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.

Jan 3, 2023 Other Medical Devices Nationwide View Details →