Z-0038-2007

DeVilbiss iFill Personal Oxygen Station model number 535D

Name: Z-0038-2007 DeVilbiss iFill Personal Oxygen Station model number 535D
Creator: Sunrise Medical
Published: 2006-08-24
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2006-08-24 / Terminated

FDA source

Sunrise Medical began a recall of DeVilbiss iFill Personal Oxygen Station model number 535D on 2006-08-24. The reason FDA records is "Potential for oxygen cylinders to not fill completely". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0038-2007
Status: Terminated
Initiated: 2006-08-24
Posted: 2006-10-17
Terminated: 2009-08-27
Recalling firm: Sunrise Medical, Inc.
Product: DeVilbiss iFill Personal Oxygen Station model number 535D.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Potential for oxygen cylinders to not fill completely
FDA root cause: Other
Action: The recalling firm began to notify customers via telephone beginning on 8/24/06. An 'Urgent Medical Device Recall' letter was sent on 8/28/06. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. A customer service help line has been established (1-800-333-4000) to provide additional information for returning units.
Quantity in commerce: 252 units
Distribution: The product was distriubted to 252 end users nationwide through 36 dealers.
Product codes and lots: serial numbers AD01145 through AD01462

Product code CAW

K053240Class IIDevilbiss Oxygen Cylinder Filling System, 535 SeriesSunrise Medical / cleared 2006-02-03

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)