The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0267-2022·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II medical device recall with no reported illnesses, injuries, or hospitalizations. The hazard involves potential battery rupture and emission of fumes and smoke, presenting a risk of harm but without actual reported injury.

Plain-English summary

Western/Scott Fetzer Company is recalling the Roberts Digital VIPR System (Model ROC-9840) with E-size cylinder due to a battery rupture hazard. The internal battery can rupture, causing the plastic VIPR shroud to break apart and emit fumes and smoke.

The affected units were distributed to Connecticut, Maryland, Montana, and Ohio between May 29, 2020, and August 31, 2021. Approximately 11,341 units are included in this recall. Units distributed after August 31, 2021, are outside the scope of this recall and can be identified by a green and silver control knob sticker.

Consumers should stop using affected Roberts Digital VIPR System units immediately and contact the manufacturer for assistance or replacement.

The recalled product

Product
Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
Manufacturer
Western/Scott Fetzer Company
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
11,341

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 →

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