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U.S. Department of Health and Human Services

Medical Devices

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Nidek Medical Products, Inc., Mark 5 Nuvo, Nuvo 8 and Nuvo Lite Oxygen Concentrators

Recall Class: Class I

Date Recall Initiated: May 1, 2012

Products: Mark 5 Nuvo, Nuvo 8 and Nuvo Lite Oxygen Concentrators
Serial numbers range from 042-10000 through 102-09335

These oxygen concentrators were manufactured from January 1, 2004 to May 15, 2010.

Use: Oxygen concentrators are normally used to supply supplemental oxygen to patients within a home setting. 

Recalling Firm:

Nidek Medical Products, Inc.

3949 Valley East Industrial Drive

Birmingham, Alabama 35217

Reason for Recall:

Capacitor failure may result in a fire hazard and loss of supplemental oxygen. These products may cause serious adverse health consequences, including death.

Public Contact:

Consumers may contact the firm at Nidek Medical Products, Inc. at 1-205-856-7200 ext 242 or by e-mail at fieldcorrection@nidekmedical.com

FDA District: New Orleans District Office

FDA Comments:

On May 1, 2012, the firm sent its distributors a Field Correction notice. In the notice, the firm asked their distributors to contact their customers and/or patients who brought these products.

CONSUMERS: Notify your equipment provider if you have an affected product in your home or place of business. According to the firm, patients may continue to use the device while waiting for a replacement for the corrected component.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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