The Recall Desk

Manufacturer

Nidek Medical Products Inc

9 recalls in our database name Nidek Medical Products Inc as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
8
Most recent
2012-06-27

Of the 9 recalls from Nidek Medical Products Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (89%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • SevereFDA (Devices)·Z-1775-2012·2012-06-27

    Nidek Medical Oxygen Concentrator Recalled for Fire Hazard

    Nidek Medical is recalling M5C5/Mark5 Nuvo/OCSI oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.

    Product
    NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1782-2012·2012-06-27

    Nidek Medical Oxygen Concentrator Recalled for Fire Hazard

    Nidek Medical is recalling MARK5 NUVO oxygen concentrators because a capacitor failure could cause a fire and stop oxygen supply.

    Product
    NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1774-2012·2012-06-27

    Nidek Medical Oxygen Concentrator Recalled for Fire Hazard

    Nidek Medical is recalling 7,889 oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.

    Product
    NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1781-2012·2012-06-27

    Nidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard

    Nidek Medical is recalling NUVO LITE oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.

    Product
    NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1777-2012·2012-06-27

    Nidek Medical Oxygen Concentrator Recalled for Fire Hazard

    Nidek Medical is recalling 335 MARK5 NUVO 8 oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.

    Product
    NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1776-2012·2012-06-27

    Nidek Medical Oxygen Concentrator Recalled for Fire Hazard

    Nidek Medical is recalling 82 MARK5 NUVO 8 STD oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.

    Product
    NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1780-2012·2012-06-27

    Nidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard

    Nidek Medical is recalling 14,585 NUVO LITE oxygen concentrators worldwide because a capacitor failure could cause a fire or loss of supplemental oxygen.

    Product
    NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1779-2012·2012-06-27

    Nidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard

    Nidek Medical is recalling 3,638 NUVO LITE oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.

    Product
    NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2012·2012-06-27

    Nidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard

    Nidek Medical is recalling 730 NUVO LITE oxygen concentrators because a capacitor failure could cause a fire or loss of oxygen.

    Product
    NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
    Category
    Medical Device
    Distribution
    Distributed nationwide