CLASS I Device recall · Reported 29 Jul 2015 · FDA Enforcement Report
Various OxyTOTE Portable Oxygen System regulators recalled
Western / Scott Fetzer is recalling Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, distributed in 48 states. The recall was initiated on 31 Jan 2015 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2069-2015
- FDA event ID
- 70163
- Recalling firm
- Western / Scott Fetzer, Westlake, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 31 Jan 2015
- FDA classified
- 20 Jul 2015
- Reported
- 29 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 31 Jan 2015 | Recall initiated by company | |
| 20 Jul 2015 | Classified by FDA | +170 days |
| 29 Jul 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Various 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.
Where it was distributed
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.
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
The recall affects all lot numbers (made prior to 10/01/2014) for the following Model Numbers: AAG-403; AAG-800; AAG-802; AAG-803; GTS-303; GTS-4206; GTS-600; GTS-603; JHR-900; JHR-LG-MTS-903; LAW-603; MNR-3000; MNR-600; MNR-800; MNS-602; MNS-603;; MNS-803; MNS-C803; MTR-100; MTR-300; MTR-500; MTR-600; MTR-700; MTR-800; MTS-303; MTS-403; MTS-501; MTS-502; MTS-503; MTS-505; MTS-601; MTS-602; MTS-603; MTS-803; OXC-503; PHS-LG-MTS-803; ROC-9792; ROC-9793; RRI-500; RRI-600; TRI-803; VLB-603; VLB-603H; VNG-600; VNG-603; VNG-800; and WOX-603.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Western / Scott Fetzer
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|---|---|---|---|---|---|
| Device | CLASS II | Digital Vipr Roc-9839 Roberts Oxygen Ready to Use Digital recalled | Western/Scott Fetzer | Device Malfunction | Nationwide |
| Device | CLASS II | Roberts Digital VIPR System (with E-size cylinder) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
| Device | CLASS II | Western Oxytote DTE Digital VIPR (head only) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
| Device | CLASS II | Western Oxytote DTE Digital VIPR System (with E-size cylinder) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
| Device | CLASS II | Western Oxytote DTE Digital VIPR System (with D-size cylinder) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
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