Western/Scott Fetzer Company: Medical Device Recall in 2021 - (Recall #: Z-0268-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 16, 2021

Date Posted: December 1, 2021

Recall Number: Z-0268-2022

Event ID: 88877

Reason for Recall:

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

Status: Ongoing

Product Quantity: 4974 units

Code Information:

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 Pattern:

CT, MD, MT, OH

Voluntary or Mandated:

Voluntary: Firm initiated