Data Foundry

Medical device recalls 2012

NIDEK Medical NUVO LITE MODEL 525 OCSI — Class I medical device recall Z-1778-2012

Terminated recall by Nidek Medical Products Inc, reported 2012-06-27, distributed nationwide. Capacitor failure may result in a fire hazard and loss of supplemental oxygen.

Recall numberZ-1778-2012
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmNidek Medical Products Inc, Birmingham, AL, United States
Recall initiated2012-05-01
Classified2012-06-19
Reported by FDA2012-06-27
Terminated2017-03-21
DistributedNationwide (US)
Countries outside the USAE, AT, AU, BE, BG, BO, CH, CL, CN, CO, CR, CY, CZ, DE, DZ, EC, EG, ES, FR, GB, GR, GT, HK, ID, IE, IL, IN, IR, IT, JP, KR, KW, LB, LT, MA, MX, MY, NG, NL, NP, NZ, PE, PK, PT, RS, RU, SA, SG, SK, SV, TH, TN, TR, TW, VN, ZA
Quantity730 units
Serial numbers042-10000
Model numbers525

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1778-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.