Lower risk Medical device recall · FDA · Published August 15, 2019

Western/Scott Fetzer Grab n Go Opti VIPR System Model PRX-9646 Recall: Limited Flow

Western/Scott Fetzer recalls Grab n Go Opti VIPR system Model PRX-9646 due to limited access to flow settings from control knob rotation. This device is for emergency oxygen use only.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0342-2020Medical device Western/Scott Fetzer ›

Lower-risk recall

Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

Take action

Contact the company

Recalling firmWestern / Scott Fetzer Company875 Bassett Rd · Westlake, OH 44145-1142

✎ GovInfoNow plain-language explainer

Western/Scott Fetzer is recalling their Grab n Go Opti VIPR system model PRX-9646 because the control knob can be rotated beyond its functional range, limiting access to flow settings. This could affect patients receiving oxygen therapy. Read more at govinfonow.com/recall/67188-western-scott-fetzer-grab-n-go-opti-vipr-system-model.

Source Summary by GovInfoNow · govinfonow.com/recall/67188-western-scott-fetzer-grab-n-go-opti-vipr-system-model · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0342-2020

Cite this page

“Western/Scott Fetzer Grab n Go Opti VIPR System Model PRX-9646 Recall: Limited Flow.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67188-western-scott-fetzer-grab-n-go-opti-vipr-system-model. Based on FDA recall #Z-0342-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0342-2020%22&limit=1).

The FDA announced on August 15, 2019, that Western/Scott Fetzer Company is recalling the Grab n Go Opti series VIPR system Model # PRX-9646. The hazard involves limited access to flow settings due to a control knob rotated beyond its functional range.

How to tell if you have it

Brand: Western/Scott Fetzer
Product: Grab n Go Opti series VIPR system
Model #: PRX-9646
Lot dates: 08/31/14 to 08/07/2019
Quantity: 25,840 units

The hazard

The control knob may have been rotated beyond its functional range, resulting in limited access to flow settings. The device is an integrated delivery system intended to provide supplemental oxygen by prescription only.

Context

GovInfoNow's records show Western/Scott Fetzer Company has issued two other recalls since October 16, 2021. On January 3, 2023, the company recalled Digital VIPR Oxygen Tanks due to incorrect pressure gauges that may cause oxygen depletion. On October 16, 2021, Western Oxytote DTE Digital VIPR Systems were recalled for battery rupture risks. Other recent recalls of similar products include Vortex Surgical TID Pharos Illuminated Depressor (December 16, 2025), Datex-Ohmeda Aisys Anesthesia System (July 30, 2026), and Olympus UHI-4 Insufflation Unit (June 16, 2026).

How to tell if you have this one

Check for the model number PRX-9646 on the device. This product was sold from August 31, 2014, through August 7, 2019.

Brand
Western/Scott Fetzer
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico.

Recall number	Product, codes & lots	Quantity
Z-0339-2020	Grab n Go Opti series VIPR system Model # PRX-9615 - 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 resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.; All Lot manufactured from 08/31/14 to 08/07/2019	1,287 units
Z-0340-2020	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 resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.; All Lot manufactured from 08/31/14 to 08/07/2019	143,164 units
Z-0341-2020	Grab n Go Opti series VIPR system Model # PRX-9632 - 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 resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.; All Lot manufactured from 08/31/14 to 08/07/2019	6,790 units
Z-0342-2020	Grab n Go Opti series VIPR system Model # PRX-9646 - 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 resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.; All Lot manufactured from 08/31/14 to 08/07/2019	25,840 units
Z-0343-2020	Grab n Go Opti series VIPR system Model # PRX-9653 - 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 resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.; All Lot manufactured from 08/31/14 to 08/07/2019	486 units

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model number PRX-9646 on the device to confirm it is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

Aug 15, 2019Firm started the recall
Nov 6, 2019FDA classified it Class II
Nov 13, 2019Published in FDA’s Enforcement Report
Nov 18, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/67188-western-scott-fetzer-grab-n-go-opti-vipr-system-model">Western/Scott Fetzer Grab n Go Opti VIPR System Model PRX-9646 Recall: Limited Flow (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0342-2020 (August 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0342-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.