Medical device recalls High risk

JMC5A Ni/TruAire-5 Oxygen Concentrator recalled over fire hazard

Recall date
December 9, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD recalls JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Recall number
Z-0795-2025
FDA classification
Class I
Brand / firm
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
Sold / distributed
US: OH

Why it was recalled

Oxygen concentrator may melt or catch on fire during use.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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