Portable Oxygen Generator recallZ-1368-05 · Inogen, Inc · initiated Aug 1, 2005
Terminated All recalls posted in August 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Inogen, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.
FDA root cause category: Other
What the company is doing
Recall is scheduled to begin August 1st 2005 by letter to customers informing them that the units will be upgraded on a predetermined schedule. Firm estimates completion in 6 months.
Recall details
- Recall number
- Z-1368-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 1, 2005
- Posted by the FDA
- Aug 12, 2005
- Recalling firm
- Inogen, Inc
- Quantity
- 900
- Product code
- CAW
- FDA submissions
- K032818
- Distribution
- Nationwide
Product description
Portable Oxygen Generator
Code information (models, lots, serial numbers)
All codes.
Other devices under the same FDA submission
9 devices cleared under K032818 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Inogen One G5 Oxygen Concentrator - Bluetooth 1260 BluetoothInogen, Inc. · Generator, Oxygen, Portable3 deaths235 reports
- Inogen One G3 Oxygen Concentrator 1050Inogen, Inc. · Generator, Oxygen, Portable2 deaths111 reports
- Inogen One G4 Oxygen Concentrator - Bluetooth 630 BluetoothInogen, Inc. · Generator, Oxygen, Portable1 death43 reports
- Inogen One G4 Oxygen Concentrator 630Inogen, Inc. · Generator, Oxygen, Portable25 reports
- Inogen One G3 Oxygen Concentrator 840Inogen, Inc. · Generator, Oxygen, Portable14 reports
- Inogen One G3 Oxygen Concentrator 840Inogen, Inc. · Generator, Oxygen, Portable2 reports
- Inogen One G3 Oxygen Concentrator 1050Inogen, Inc. · Generator, Oxygen, Portable1 report
- OxyGo 1050Inogen, Inc. · Generator, Oxygen, Portable1 report
- OxyGo Fit 630Inogen, Inc. · Generator, Oxygen, Portable1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page