Oxygen Concentrator May Catch Fire or Melt During Use
The JMC5A Ni/TruAire-5 Oxygen Concentrator (Model O2C5L) is being recalled. The device may catch fire or melt during use, creating a risk of serious injury from fire and burns.
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: FDA Class I classification carries a minimum severity rating of Severe. The hazard—potential fire and melting during use—creates a significant risk of serious injury and property damage, even though no incidents have been reported to date.
Plain-English summary
The JMC5A Ni/TruAire-5 Oxygen Concentrator (Model O2C5L) is being recalled because the device may catch fire or melt during use. This creates a serious risk of fire, burns, and property damage to users who depend on this medical device.
The recall affects approximately 6,520 units distributed in Ohio. Affected units have serial numbers within the ranges beginning with JA2311, JA2312, and JA2401. The product identifier (UDI-DI) is 00092237623152.
If you own or operate this oxygen concentrator, stop using it immediately. Contact the manufacturer, JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD, for instructions on return, replacement, or repair options. Do not attempt to repair or troubleshoot the device yourself.
The recalled product
- Product
- JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
- Manufacturer
- JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
- Hazard
- Affected units
- 6,520
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 (9)
- UDI-DI: 00092237623152. Serial Number Ranges: JA2311000001-JA2311000740
- JA2311000741-JA2311001480
- JA2311001481-JA2311002220
- JA2311002221-JA2311002960
- JA2311002961-JA2311003700
- JA2312000001-JA2312000740
- JA2312000741-JA2312001480
- JA2312001481-JA2312002080
- JA2401000001-JA2401000740.
Distribution
Distributed in 1 state:
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