CLASS I ONGOING Device recall · Reported 15 Jan 2025 · FDA Enforcement Report
JMC5A Ni/TruAire-5 Oxygen Concentrator recalled
Jiangsu Jumao X-care Medical Equipment is recalling JMC5A Ni/TruAire-5 Oxygen Concentrator, distributed in Ohio. The recall was initiated on 9 Dec 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0795-2025
- FDA event ID
- 95818
- Recalling firm
- Jiangsu Jumao X-care Medical Equipment, Danyang
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 9 Dec 2024
- FDA classified
- 3 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 9 Dec 2024 | Recall initiated by company | |
| 3 Jan 2025 | Classified by FDA | +25 days |
| 15 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Oxygen concentrator may melt or catch on fire during use.
Product as listed by the FDA
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Where it was distributed
US: OH
Questions about this recall
Why was it recalled?
Oxygen concentrator may melt or catch on fire during use.
Which lots are affected?
UDI-DI: 00092237623152. Serial Number Ranges: JA2311000001-JA2311000740, JA2311000741-JA2311001480, JA2311001481-JA2311002220, JA2311002221-JA2311002960, JA2311002961-JA2311003700, JA2312000001-JA2312000740, JA2312000741-JA2312001480, JA2312001481-JA2312002080, JA2401000001-JA2401000740.
Where was it sold?
US: OH
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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