Z-0795-2025Class I

JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

Name: Z-0795-2025 JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Creator: Jiangsu Jumao X-Care Medical Equipment Co Ltd
Published: 2024-12-09
License: https://open.fda.gov/license/

Jiangsu Jumao X-Care Medical Equipment Co., Ltd / initiated 2024-12-09 / Open, Classified

FDA source

JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD began a recall of JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L on 2024-12-09. FDA classified it as Class I and gives the reason as "Oxygen concentrator may melt or catch on fire during use". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0795-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-12-09
Posted: 2025-01-03
Recalling firm: Jiangsu Jumao X-Care Medical Equipment Co., Ltd
Product: JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Oxygen concentrator may melt or catch on fire during use.
FDA 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 [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.
Quantity in commerce: 6,520
Distribution: US: OH
Product codes and lots: UDI-DI: 00092237623152. Serial Number Ranges: JA2311000001-JA2311000740, JA2311000741-JA2311001480, JA2311001481-JA2311002220, JA2311002221-JA2311002960, JA2311002961-JA2311003700, JA2312000001-JA2312000740, JA2312000741-JA2312001480, JA2312001481-JA2312002080, JA2401000001-JA2401000740.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0795-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0795-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-03

Product code CAW

K230969Class IIOxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd. / cleared 2023-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)