RecallRadar
FDA · Medical devicesClass I

Jiangsu Jumao X-care Medical Equipment Co Ltd medical device recall: JMC5A Ni/TruAire-5 Oxygen Concentrator

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
95818
Recall initiated
Dec 9, 2024
Classified by FDA
Jan 3, 2025
Posted in Enforcement Report
Jan 15, 2025
Recalling firm
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
Firm location
Danyang, China
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
1

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

Oxygen concentrator may melt or catch on fire during use.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Dec 9, 2024. FDA classified it 25 days later, on Jan 3, 2025. Distribution reported by FDA: US: OH

Recalled products (1)

  • Z-0795-2025 Class I Ongoing

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

    Codes / 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.

    Quantity: 6,520

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 95818
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.