The Recall Desk
HighFDA (Devices)·Z-0268-2022·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device recall involving a battery rupture hazard that could cause harm through fume and smoke emission. Per the severity rubric, this qualifies as High (score 3): a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Western/Scott Fetzer Company is recalling the Western Oxytote DTE Digital VIPR (head only), Model MNDR-600. The recall is due to a battery rupture hazard that can cause the plastic VIPR shroud to break apart and emit fumes and smoke.

Approximately 4974 units were distributed between May 29, 2020, and August 31, 2021, in Connecticut, Maryland, Montana, and Ohio. Devices manufactured and distributed after August 31, 2021, are not affected and can be identified by a green and silver control knob sticker.

Healthcare facilities and users should immediately stop using affected devices. Contact Western/Scott Fetzer Company for return or replacement instructions. Do not use devices from the recall distribution period that lack the green and silver control knob sticker.

The recalled product

Product
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
Manufacturer
Western/Scott Fetzer Company
Category
Medical Device — Pressure Regulator Device
Hazard
Affected units
4,974

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • silver background)

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 4 recalled by Western/Scott Fetzer Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Western/Scott Fetzer Company

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Same hazard · battery rupture

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