CLASS II ONGOING Device recall · Reported 1 Dec 2021 · FDA Enforcement Report

Western Oxytote DTE Digital VIPR (head only) recalled

Western/Scott Fetzer is recalling Western Oxytote DTE Digital VIPR (head only), distributed in Connecticut, Maryland, Montana, Ohio. The recall was initiated on 16 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUnits 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)

Quantity recalled4974 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0268-2022
FDA event ID: 88877
Recalling firm: Western/Scott Fetzer, Westlake, OH
Classification: Class II
Status: Ongoing
Recall initiated: 16 Oct 2021
FDA classified: 19 Nov 2021
Reported: 1 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

16 Oct 2021	Recall initiated by company
19 Nov 2021	Classified by FDA	+34 days
1 Dec 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

CT, MD, MT, OH

Connecticut Maryland Montana Ohio

Questions about this recall

Is Western Oxytote DTE Digital VIPR (head only) recalled?

Yes. Western/Scott Fetzer recalled Western Oxytote DTE Digital VIPR (head only) on 16 Oct 2021. The recall is Class II and its status is Ongoing. Recall number Z-0268-2022.

Why was it recalled?

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

Which lots are affected?

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)

Where was it sold?

CT, MD, MT, OH

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Western/Scott Fetzer

All 12

Reported	Class	Recall	Company	Reason	Where
19 Apr 2023Device	CLASS II	Digital Vipr Roc-9839 Roberts Oxygen Ready to Use Digital recalled	Western/Scott Fetzer	Lead & Heavy Metals	Nationwide
1 Dec 2021Device	CLASS II	Roberts Digital VIPR System (with E-size cylinder) recalled	Western/Scott Fetzer	Foreign Material	4 states
1 Dec 2021Device	CLASS II	Western Oxytote DTE Digital VIPR System (with E-size cylinder) recalled	Western/Scott Fetzer	Foreign Material	4 states
1 Dec 2021Device	CLASS II	Western Oxytote DTE Digital VIPR System (with D-size cylinder) recalled	Western/Scott Fetzer	Foreign Material	4 states
13 Nov 2019Device	CLASS II	Grab n Go Opti series VIPR system recalled by Western / Scott Fetzer	Western / Scott Fetzer	Other	Nationwide

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