Regulator, Pressure, Gas Cylinder
Anesthesiology · 21 CFR 868.2700
Recent MDR events
646 adverse event reports on file
- MEDIREG IIJul 29, 2026MalfunctionGce, S.r.o.3003207908-2026-00003
- MEDLINEJun 25, 2026MalfunctionMedline Industries, Lp1417592-2026-02254
- MEDLINEJun 12, 2026MalfunctionMedline Industries, Lp1417592-2026-02406
- MEDLINEJun 11, 2026MalfunctionMedline Industries, Lp1417592-2026-02363
- MEDLINEJun 11, 2026MalfunctionMedline Industries, Lp1417592-2026-02326
- MEDLINEJun 11, 2026MalfunctionMedline Industries, Lp1417592-2026-02328
- MEDLINEJun 11, 2026MalfunctionMedline Industries, Lp1417592-2026-02355
- MEDLINEJun 11, 2026MalfunctionMedline Industries, Lp1417592-2026-02324
- MEDLINEJun 11, 2026MalfunctionMedline Industries, Lp1417592-2026-02305
- MEDLINEJun 11, 2026MalfunctionMedline Industries, Lp1417592-2026-02376
Event type breakdown
Recalls
17 recall events for this product code
- Western/Scott Fetzer CompanyOpen, ClassifiedApr 12, 2023
Digital VIPR
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.
Z-1376-2023 · View FDA record ↗ - Precision Medical, Inc.TerminatedNov 13, 2015
Easy Dial Oxygen Regulator, 168708D and 168715D.
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).
Z-0272-2016 · View FDA record ↗ - Western / Scott Fetzer CompanyTerminatedJul 20, 2015
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package.
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.
Z-2069-2015 · View FDA record ↗ - Western / Scott Fetzer CompanyTerminatedJun 23, 2014
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
Separation events have occurred, including the VIPR separating from the Aluminum cylinder.
Z-1849-2014 · View FDA record ↗ - Linde Gas North America LlcTerminatedJun 20, 2013
MEDICYCL-E- Lite Portable Oxygen System
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Z-1561-2013 · View FDA record ↗ - Praxair Inc.TerminatedDec 21, 2012
Praxair Vantage Grab n Go - Gas Cylinder pressure regulator
Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.
Z-0525-2013 · View FDA record ↗ - Western - a Scott Fetzer CompanyTerminatedOct 15, 2009
Medical Gas Yoke Assembly. Generic 4-Cylinder Manifold Cart Model #8070.
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.
Z-0059-2010 · View FDA record ↗ - Western - a Scott Fetzer CompanyTerminatedOct 15, 2009
Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238.
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.
Z-0060-2010 · View FDA record ↗ - Western - a Scott Fetzer CompanyTerminatedOct 15, 2009
Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237.
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.
Z-0061-2010 · View FDA record ↗ - Airgas Puritan MedicalTerminatedOct 14, 2009
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.
Z-0037-2010 · View FDA record ↗
Registered firms
117 firms currently registered for this product code
Dragon Medical Co.,ltd
Suzhou City Jiangsu, CN
Danyang Xinya Valve Co., Ltd.
Danyang Jiangsu, CN
J Summit Co., Ltd.
Chomthong Krung Thep Maha Nakhon, TH
Medline Industries, Lp - Northfield
Northfield, IL, US
Flotec, Inc.
Eagle Creek, IN, US
Jiangsu Jumao X-care Medical Equipment Co., Ltd
Danyang Jiangsu, CN
Headstar Medical Products Co., Ltd
NEW TAIPEI CITY, TW
Baxter R&d Europe Srl
Braine-l'Alleud Wallonia, BE
Allied Medical Llc
Earth City, MO, US
Ceodeux S.a.
LINTGEN Luxembourg, LU
Icu Medical, Inc.
DUBLIN, OH, US
Linde Gas & Equipment Inc.
TONAWANDA, NY, US
Accutron, Inc.
PHOENIX, AZ, US
Kls Martin Se & Co. Kg
Freiburg Baden-Wurttemberg, DE
Tescom Europe Gmbh & Co. Kg
Selmsdorf Mecklenburg-Western Pomerania, DE
Vygon S A
ECOUEN 95440 Val-d'Oise, FR
Shanghai Tianhai Composite Cylinders Co., Ltd.
Shanghai, CN
Besmed Health Business Corporation
New Taipei City, TW
Control Devices - Carr Lane
Saint Louis, MO, US
Bound Tree Medical, Llc
Grand Prairie, TX, US
Medsource Labs, Llc
Chanhassen, MN, US
Sunset Healthcare Solutions Warehouse
Phoenix, AZ, US
Controls Corporation Of America
Virginia Beach, VA, US
510(k) clearances
55 clearances for this product code
- Essex Industries, Inc.Mar 2, 2017
K162811 · MR Conditional CGA 870
- San Cheong Co. , Ltd.Apr 7, 2009
K080243 · PORTABLE OXYGEN UNIT SCA900
- Remcore, Inc.Oct 25, 2006
K060265 · REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
- Responsive Respiratory, Inc.Sep 7, 2006
K061785 · CYL-FIL OXYGEN SYSTEM
- Mada Medical Products, Inc.Apr 14, 1995
K950777 · OXYGEN REGULATOR
- Buckman Co., Inc.Feb 9, 1995
K942751 · VANGUARD SERIES GAS REGULATORS
- Life Support Products, Inc.Jan 27, 1994
K936187 · LSPI PRESSURE REGULATOR
- Precision Medical, Inc.Oct 25, 1993
K932006 · 1500 SERIES REGULATOR