Recall Register

Western/Scott Fetzer Company: FDA recalls

FDA enforcement reports name Western/Scott Fetzer Company as the recalling firm in 5 events. The events have 12 product records. The recalls started from 2014 to 2023. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

5 events, newest first.

FDA enforcement events of Western/Scott Fetzer Company
InitiatedProduct (first record)TypeClassRecordsStatus
3 Jan 2023Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE…DeviceClass II1Ongoing
16 Oct 2021Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840DeviceClass II4Ongoing
15 Aug 2019Grab 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…DeviceClass II5Terminated
31 Jan 2015Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.DeviceClass I1Terminated
7 Apr 2014Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Western/Scott Fetzer Company: events for each product type
TypeEvents
Device5
Western/Scott Fetzer Company: events in each class
ClassEvents
Class II4
Class I1
Share of the events of the firm in Class I
20%
Share of all events on the register in Class I
18%
Events with the status Ongoing
2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Western/Scott Fetzer Company, by the year that the recall started. The largest year is 2014, with 1 event.

Official channels

Cite this page

Recall Register. Western/Scott Fetzer Company: FDA recalls. https://recallregister.com/firm/western-scott-fetzer-company/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
OH

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Western/Scott Fetzer Company have?
Class II: 4 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Western/Scott Fetzer Company?
FDA event 91561, which the firm started on 3 Jan 2023. The first product in the record is: Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE…
How many FDA recalls of Western/Scott Fetzer Company have the status Ongoing?
2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.