Z-1473-2008

Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02...

Name: Z-1473-2008 Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02...
Creator: Medline Industries Inc
Published: 2008-03-04
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2008-03-04 / Terminated / root cause: design

FDA source

Medline Industries Inc began a recall of Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen... on 2008-03-04. The reason FDA records is "Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1473-2008
Status: Terminated
Initiated: 2008-03-04
Posted: 2008-07-23
Terminated: 2010-06-17
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified by a letter sent on 3/4/08. The letter informed users that the recalling firm will replace the affected units with new units or issue a credit for the returned recalled units. Distributors were requested to notify their accounts of the recall. The letter requested users to complete and return an enclosed response sheet, indicating the number of units to be replaced or returned for credit. For additional information, contact 866-359-1704.
Distribution: Nationwide Distribution
Product codes and lots: Reorder Number: HCS02; All units produced since July 2006.

Product code CAW

K043520Class IIEMG Cta01-Xxx Series Puro Oxygen ConcentratorEmg Technology Co., Ltd. / cleared 2005-10-21

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)