Invacare® Platinum® 5NXG Oxygen Concentrator P5NXG1Recalls & reported problems
Invacare Corporation · ASM, FINAL PLATINUM 5NXG NA · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jun 10, 2022Class IIIOpen, Classified
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Z-1369-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Other Generator, oxygen, portable devices
- DeVilbiss 525DSDevilbiss Healthcare LLC · Generator, Oxygen, Portable2 recalls14 deaths287 reports
- Inogen One G5 Oxygen Concentrator - Bluetooth 1260 BluetoothInogen, Inc. · Generator, Oxygen, Portable3 deaths235 reports
- EverFlo EverFlo w/O2 Percentage Indicator, 230V, EURespironics, Inc. · Generator, oxygen, portable5 deaths112 reports
- Inogen One G3 Oxygen Concentrator 1050Inogen, Inc. · Generator, Oxygen, Portable2 deaths111 reports
- DeVilbiss 125DDevilbiss Healthcare LLC · Generator, Oxygen, Portable2 recalls1 death3 reports
- EverFlo EVERFLO NON-O2 Percentage Indicator, 120V, US,CARespironics, Inc. · Generator, oxygen, portable19 deaths80 reports
- EverFlo EVERFLO w/Oxygen Percentage Indicator, 120V US, CARespironics, Inc. · Generator, oxygen, portable2 deaths71 reports
- SimplyGo Mini SimplyGo Mini, USRespironics, Inc. · Generator, oxygen, portable1 recall1 death5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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