FDA recall Z-0795-2025
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD · Class I · device
Product
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Reason for recall
Oxygen concentrator may melt or catch on fire during use.
Distribution
US: OH
Key facts
- Status
- Ongoing
- Initiation date
- 2024-12-09
- Report date
- 2025-01-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Danyang, China
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0795-2025