FDA Medical Device Recalls (openFDA)
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD: JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
- Recall number
- Z-0795-2025
- Recalling firm
- JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
- Product
- JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
- Status
- Open, Classified
- Initiated
- 2024-12-09
- Posted
- 2025-01-03
- Terminated
- not on file
- Reason
- Oxygen concentrator may melt or catch on fire during use.
- Root cause
- Component change control
- Action
- 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.
- Quantity
- 6,520
- Distribution
- US: OH
- Lot, serial or model codes
- UDI-DI: 00092237623152. Serial Number Ranges: JA2311000001-JA2311000740, JA2311000741-JA2311001480, JA2311001481-JA2311002220, JA2311002221-JA2311002960, JA2311002961-JA2311003700, JA2312000001-JA2312000740, JA2312000741-JA2312001480, JA2312001481-JA2312002080, JA2401000001-JA2401000740.
- 510(k) numbers
- ["K230969"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 3014810929
- Firm city
- Lianxing Village Danyang
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28