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.
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 source explicitly identifies a fire hazard and loss of supplemental oxygen, which constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
Nidek Medical Products Inc is recalling the NIDEK Medical M5C5/ MARK5 NUVO/OCSI oxygen concentrator (230 V~50/60 Hz -420 W). The recall involves units with serial numbers 042-10000 through 102-07044.
The recall is being conducted because a capacitor failure may result in a fire hazard and the loss of supplemental oxygen. This product was distributed nationwide in the United States and in numerous countries worldwide, including 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, Lebanon, Libya, Lithuania, Malaysia, Mexico, Morocco, Myanmar, Namibia, Nepal, New Zealand, Nigeria, Pakistan, Peru, Philippines, Portugal, Republic of China, Republic of South Africa, Russia, Serbia, Singapore, Slovakia, South Africa, South Australia, South Korea, Spain, Switzerland, Taiwan, Tanzania, Thailand, The Netherlands, Togo, Tunisia, Turkey, Uganda, United Arab Emirates, and Vietnam.
Consumers should contact Nidek Medical Products Inc for further instructions on how to address this safety issue.
The recalled product
- Product
- NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
- Manufacturer
- Nidek Medical Products Inc
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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