CLASS I Device recall · Reported 27 Jun 2012 · FDA Enforcement Report

Nidek Medical Nuvo Lite recalled

Nidek Medical Products is recalling Nidek Medical Nuvo Lite, distributed nationwide in the US. The recall was initiated on 1 May 2012 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesSerial numbers 042-10000 through 102-07044

Quantity recalled730 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1778-2012
FDA event ID: 61843
Recalling firm: Nidek Medical Products, Birmingham, AL
Classification: Class I
Status: Terminated
Recall initiated: 1 May 2012
FDA classified: 19 Jun 2012
Reported: 27 Jun 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

1 May 2012	Recall initiated by company
19 Jun 2012	Classified by FDA	+49 days
27 Jun 2012	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Capacitor failure may result in a fire hazard and loss of supplemental oxygen.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of ALBANIA, ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ENGLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, KAZAKHSTAN, KINGDOM OF SAUDI ARABIA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NEPAL, NEW ZEALAND, NIGERIA, PAKISTAN, PERU, PHILIPPPINES, PORTUGAL, REPUBLIC OF CHINA, REPUBLIC OF SOUTH AFRICA, RUSSIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH AUSTRALIA, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, THE NETHERLANDS, TOGO, TUNISIA, TURKEY, UGANDA, UNITED ARAB EMIRATES, and VIETNAM.

Nationwide

Questions about this recall

Is Nidek Medical Nuvo Lite recalled?

Yes. Nidek Medical Products recalled Nidek Medical Nuvo Lite on 1 May 2012. The recall is Class I and its status is Terminated. Recall number Z-1778-2012.

Why was it recalled?

Capacitor failure may result in a fire hazard and loss of supplemental oxygen.

Which lots are affected?

Serial numbers 042-10000 through 102-07044

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nidek Medical Products

All 9

Reported	Class	Recall	Company	Reason	Where
27 Jun 2012Device	CLASS I	Nidek Medical Nuvo Lite recalled	Nidek Medical Products	Device Malfunction	Nationwide
27 Jun 2012Device	CLASS I	Nidek Medical Nuvo Lite recalled	Nidek Medical Products	Device Malfunction	Nationwide
27 Jun 2012Device	CLASS I	Nidek Medical MARK5 Nuvo / M5C5, 115 V ~60Hz - 410 W recalled	Nidek Medical Products	Device Malfunction	Nationwide
27 Jun 2012Device	CLASS I	Nidek Medical M5C5/ MARK5 Nuvo/Ocsi, 230 V~50/60 Hz -420 W recalled	Nidek Medical Products	Device Malfunction	Nationwide
27 Jun 2012Device	CLASS I	Nidek Medical Nuvo Lite recalled	Nidek Medical Products	Device Malfunction	Nationwide

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