Z-1368-05

Portable Oxygen Generator

Name: Z-1368-05 Portable Oxygen Generator
Creator: Inogen, Inc
Published: 2005-08-01
License: https://open.fda.gov/license/

Inogen, Inc / initiated 2005-08-01 / Terminated

FDA source

Inogen, Inc began a recall of Portable Oxygen Generator on 2005-08-01. The reason FDA records is "Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1368-05
Status: Terminated
Initiated: 2005-08-01
Posted: 2005-08-12
Terminated: 2007-02-13
Recalling firm: Inogen, Inc
Product: Portable Oxygen Generator
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.
FDA root cause: Other
Action: 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.
Quantity in commerce: 900
Distribution: Nationwide
Product codes and lots: All codes.

Product code CAW

K032818Class IIInogen One Oxygen ConcentratorInogen, Inc. / cleared 2004-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)