The FDA has posted 5 enforcement recalls of portable oxygen generator devices since 2025, including 2 Class I (most serious) recalls. Most recent report: Apr 22, 2026.
Devices which did not meet internal quality specifications were inadvertently distributed.
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.…
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.
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
Oxygen concentrator may melt or catch on fire during use.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Generator, Oxygen, Portable”). Informational only — verify against the FDA before acting.