Regulator, Pressure, Gas Cylinder

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2023-04-12Open, ClassifiedUnder Investigation by firm

  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 Digital VIPR System (with E-size cylinder)

  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.

• 2015-11-13TerminatedError in labeling

  Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.

  These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25).

• 2015-07-20TerminatedComponent design/selection

  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.

  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.

• 2014-06-23TerminatedDevice Design

  Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)

  Separation events have occurred, including the VIPR separating from the Aluminum cylinder.

• 2013-06-20TerminatedNonconforming Material/Component

  MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

  A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.

• 2012-12-21TerminatedDevice Design

  Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.

  Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.

• 2009-10-15TerminatedComponent design/selection

  Medical Gas Yoke Assembly. Generic 4-Cylinder Manifold Cart Model #8070. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

  The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of another gas type.

• 2009-10-15TerminatedComponent design/selection

  Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

  The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of another gas type.

• 2009-10-15TerminatedComponent design/selection

  Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

  The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of another gas type.

• 2009-10-14TerminatedComponent design/selection

  AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.

  Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.