Class I — Nidek Medical Products Inc
| Recalling firm | NIDEK MEDICAL PRODUCTS, INC. |
|---|---|
| Registered facility | NIDEK MEDICAL PRODUCTS, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| Product | NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator. |
| Quantity | 3638 units |
| Distribution | 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, LEBA… |
| Initiated | 2012-05-01 |
| Classified | 2012-06-19 |
| Terminated | 2017-03-21 |
| Recall number | Z-1779-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Nidek Medical Products Inc (Z-1779-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/61843/
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