Generator, Oxygen, Portable
FDA adverse event reports and recall history for generator, oxygen, portable (product code CAW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 52,718
- Deaths
- 519
- Injuries
- 1,133
- Malfunctions
- 50,855
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
- 2026-04-15Open, ClassifiedStorage
React Health PHOENIX 5L Oxygen Concentrator
Devices which did not meet internal quality specifications were inadvertently distributed.
- 2025-11-07Open, ClassifiedNonconforming Material/Component
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
- 2025-06-13Open, ClassifiedDevice Design
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
- 2025-05-09Open, ClassifiedNonconforming Material/Component
iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
- 2025-01-03Open, ClassifiedComponent change control
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Oxygen concentrator may melt or catch on fire during use.
- 2024-11-15CompletedNonconforming Material/Component
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
Potential failure of affected units to recharge the battery of the oxygen concentrators.
- 2024-11-15CompletedNonconforming Material/Component
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Potential failure of affected units to recharge the battery of the oxygen concentrators.
- 2024-11-15CompletedNonconforming Material/Component
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
Potential failure of affected units to recharge the battery of the oxygen concentrators.
- 2024-11-15CompletedNonconforming Material/Component
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Potential failure of affected units to recharge the battery of the oxygen concentrators.
- 2023-05-04Open, ClassifiedLabeling design
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
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