FDA Medical devices recall ·
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0795-2025
- Date
- (initiated December 9, 2024)
- Company / brand
- Jiangsu Jumao X-Care Medical Equipment CO Ltd
No 36 Danyan Road, Lianxing Village, Danyang, China - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 6,520
- Hazard tags
- Fire
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Why was it recalled?
Oxygen concentrator may melt or catch on fire during use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
US: OH
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0795-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.