The Recall Desk
ModerateFDA (Devices)·Z-0340-2020·Announced 2019-11-13

Western / Scott Fetzer Recalls Grab n Go Opti VIPR Oxygen Systems

Western / Scott Fetzer is recalling 143,164 Grab n Go Opti VIPR oxygen systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves limited access to flow settings, which is a functional defect that may lead to suboptimal oxygen delivery but does not explicitly report injuries or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Western / Scott Fetzer Company is recalling 143,164 units of the Grab n Go Opti series VIPR system, Model # PRX-9627. The recall is due to a defect where the control knob may be rotated beyond its functional range, resulting in limited access to flow settings. The device is an integrated delivery system intended to provide supplemental oxygen to patients for oxygen deficiency and resuscitation.

The affected units were manufactured between August 31, 2014, and August 7, 2019. Distribution was worldwide, including US nationwide distribution in specific states and in Costa Rica and Mexico. The device is intended for emergency use and limited duration use, such as during patient transports.

Healthcare facilities and consumers should stop using the affected devices and contact Western / Scott Fetzer Company for instructions on repair or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitati
Affected units
143,164

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)

  • All Lot manufactured from 08/31/14 to 08/07/2019

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →