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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Capacitor failure may result in a fire hazard and loss of supplemental oxygen."
Plain-English summary
Nidek Medical Products Inc is recalling 730 units of the NUVO LITE MODEL 525 OCSI oxygen concentrators. The recall covers units with serial numbers ranging from 042-10000 through 102-07044. These devices were distributed nationwide in the United States and in numerous countries worldwide.
The recall is being conducted because a capacitor failure may result in a fire hazard and a loss of supplemental oxygen. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Consumers who possess these specific units should stop using them and contact Nidek Medical Products Inc for instructions on how to proceed with the recall.
The recalled product
- Product
- NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
- Manufacturer
- Nidek Medical Products Inc
- Hazard
- Affected units
- 730
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers 042-10000 through 102-07044
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Nidek Medical Products Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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See all →- SevereNidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard
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