FDA (Devices) recall action 61843
The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Nidek Medical is recalling 7,889 oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.
Nidek Medical is recalling 730 NUVO LITE oxygen concentrators because a capacitor failure could cause a fire or loss of oxygen.
Nidek Medical is recalling 14,585 NUVO LITE oxygen concentrators worldwide because a capacitor failure could cause a fire or loss of supplemental oxygen.
Nidek Medical is recalling 3,638 NUVO LITE oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.
Nidek Medical is recalling MARK5 NUVO oxygen concentrators because a capacitor failure could cause a fire and stop oxygen supply.
Nidek Medical is recalling 335 MARK5 NUVO 8 oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.
Nidek Medical is recalling NUVO LITE oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.
Nidek Medical is recalling M5C5/Mark5 Nuvo/OCSI oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.
Nidek Medical is recalling 82 MARK5 NUVO 8 STD oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.