JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD recalls JMC5A Ni/TruAire-5 Oxygen Concentrator

Oxygen concentrator may melt or catch on fire during use.

On 11/26/2024, a recall notice was sent a distributor asking them to take the steps below. On 12/09/2024, recall notices were sent from the distributor to customers who were asked to do the following: This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. All units from the specified serial number range MUST be immediately discontinued from use and removed from service and promptly returned. Complete and return the acknowledgement and receipt form via email to recall@compasshealthbrands.com If you have any questions, please contact: 1-800-376-7263 x444, Monday-Friday 8:00 am EST - 5:00 pm EST, or email recall@compasshealthbrands.com On 12/19/2024, additional recall notices were sent adding additional affected devices.

• FDA enforcement recordOfficial FDA database entry for Z-0795-2025
• FDA 510(k) clearance · K230969The device's official FDA premarket clearance record
• FDA device classification · CAWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTDSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.