Grab n Go Opti series VIPR system Model # PRX-9615 — Class II medical device recall Z-0339-2020

Terminated recall by Western / Scott Fetzer Company, reported 2019-11-13, distributed nationwide. Limited access to flow settings as a result of the control knob having been rotated beyond its functional rang

Recall number	`Z-0339-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Western / Scott Fetzer Company, Westlake, OH, United States
Recall initiated	2019-08-15
Classified	2019-11-06
Reported by FDA	2019-11-13
Terminated	2020-11-18
Distributed	Nationwide (US)
Countries outside the US	CR, MX
Quantity	1,287 units
Model numbers	`PRX-9615`

Product

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0339-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.