Reported Jul 20, 2022 · Ongoing

Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

Invacare Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Invacare Corporation · 1200 Taylor St · Elyria, OH · 44035-6248

Is this the product you have?

    • Invacare Platinum 5NXG Oxygen Concentrator
    • Model Numbers P5NXG1
    • P5NXGC1 (Canada specific model)
Lot codes and dates
  • UDI-DI00841447112075
  • Serial Number Prefixes21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX
Amount recalled
179 devices

Where it was sold

Why it was recalled

Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.