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Western/Scott Fetzer Co.

Country not established

Devices
1
FDA recalls
125 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Western/Scott Fetzer Co. makes

Western/Scott Fetzer Co. manufactures the OXYTOTE Infinity Series VIPR systems, which are designed for monitoring and controlling oxygen levels in medical environments, ensuring precise gas delivery and safety compliance.

These devices fall under FDA Class I regulation and are listed via the 510(k) pathway. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

FDA recalls12

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 12 recalls initiated by Western/Scott Fetzer Co., the earliest on 2014-04-07 and the most recent on 2023-01-03. By recorded status: 5 ongoing and 7 terminated. The reasons filed fall into these groups: electrical or power and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 5
  • 2020 0
  • 2021 4
  • 2022 0
  • 2023 1
  • 2024 0
  • 2025 0
  • 2026 0

2 initiated before 2017

Showing the 10 most recent of 12 recalls.

  • 2023

    • 3 Jan 2023 Z-1376-2023 Class II Ongoing Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use without audible alarms, potentially leading to an out of oxygen event and no flow. Distribution: US Nationwide distribution in the states of CO, CT, ID, MD, MT, TN, WA.

  • 2021

    • 16 Oct 2021 Z-0267-2022 Class II Ongoing VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke Distribution: CT, MD, MT, OH
    • 16 Oct 2021 Z-0268-2022 Class II Ongoing VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke Distribution: CT, MD, MT, OH
    • 16 Oct 2021 Z-0269-2022 Class II Ongoing VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke Distribution: CT, MD, MT, OH
    • 16 Oct 2021 Z-0270-2022 Class II Ongoing VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke Distribution: CT, MD, MT, OH

  • 2019

    • 15 Aug 2019 Z-0339-2020 Class II Terminated Limited access to flow settings as a result of the control knob having been rotated beyond its functional range Distribution: Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT,…
      Full distribution text 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.
      Submission number: K142149
    • 15 Aug 2019 Z-0340-2020 Class II Terminated Limited access to flow settings as a result of the control knob having been rotated beyond its functional range Distribution: Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT,…
      Full distribution text 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.
      Submission number: K142149
    • 15 Aug 2019 Z-0341-2020 Class II Terminated Limited access to flow settings as a result of the control knob having been rotated beyond its functional range Distribution: Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT,…
      Full distribution text 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.
      Submission number: K142149
    • 15 Aug 2019 Z-0342-2020 Class II Terminated Limited access to flow settings as a result of the control knob having been rotated beyond its functional range Distribution: Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT,…
      Full distribution text 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.
      Submission number: K142149
    • 15 Aug 2019 Z-0343-2020 Class II Terminated Limited access to flow settings as a result of the control knob having been rotated beyond its functional range Distribution: Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT,…
      Full distribution text 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.
      Submission number: K142149
Show all 12 recalls

  • 2015

    • 31 Jan 2015 Z-2069-2015 Class I Terminated The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death. Distribution: Worldwide Distribution -- US, including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut,…
      Full distribution text Worldwide Distribution -- US, including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and Wyoming; and, the countries of CANADA, CHILE, GERMANY, ISRAEL, LEBANON, MACAU, MEXICO, PUERTO RICO, and SINGAPORE.

  • 2014

    • 7 Apr 2014 Z-1849-2014 Class II Terminated Separation events have occurred, including the VIPR separating from the Aluminum cylinder. Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of Alaska, Arkansas, Arizona, California,…
      Full distribution text Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia and the countries of Canada,China, Costa Rica, France, Honduras, India, Ireland, Italy, Japan, Korea (South), Malaysia, Panama, Spain and Taiwan.

Frequently asked questions

How many devices does Western/Scott Fetzer Co. have in the registry?

The registry currently lists 1 device for Western/Scott Fetzer Co.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Western/Scott Fetzer Co.'s devices?

Among its 1 most recently registered device, Western/Scott Fetzer Co. has devices listed in FDA 510(k) (1 device).

What risk classes do Western/Scott Fetzer Co.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Western/Scott Fetzer Co.'s devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for Western/Scott Fetzer Co.?

FDA recall records list 12 recalls initiated by Western/Scott Fetzer Co., the most recent initiated on 3 Jan 2023. 5 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Western/Scott Fetzer Co. in the registry?

The most recently registered devices listed for Western/Scott Fetzer Co. include OXYTOTE INFINITY SERIES VIPR SYSTEMS.

Generated automatically from registry data and not verified by a human reviewer.