Roscoe Medical recallZ-0795-2025 · Jiangsu Jumao X-Care Medical Equipment CO Ltd · initiated Dec 9, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Jiangsu Jumao X-Care Medical Equipment CO Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Oxygen concentrator may melt or catch on fire during use.
FDA root cause category: Component change control
What the company is doing
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 [email protected] If you have any questions, please contact: 1-800-376-7263 x444, Monday-Friday 8:00 am EST - 5:00 pm EST, or email [email protected] On 12/19/2024, additional recall notices were sent adding additional affected devices.
Recall details
- Recall number
- Z-0795-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 9, 2024
- Posted by the FDA
- Jan 3, 2025
- Recalling firm
- Jiangsu Jumao X-Care Medical Equipment CO Ltd
- Quantity
- 6,520
- Product code
- CAW
- FDA submissions
- K230969
- Distribution
- US: OH
Product description
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Code information (models, lots, serial 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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Roscoe Medical O2C5LDrive Devilbiss Healthcare · Generator, Oxygen, Portable1 recall4 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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