CLASS III ONGOING Device recall · Reported 20 Jul 2022 · FDA Enforcement Report

Platinum 5NXG Oxygen Concentrator recalled by Invacare

Invacare is recalling Platinum 5NXG Oxygen Concentrator, distributed in 18 states. The recall was initiated on 10 Jun 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX

Quantity recalled179 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1369-2022
FDA event ID: 90108
Recalling firm: Invacare, Elyria, OH
Classification: Class III
Status: Ongoing
Recall initiated: 10 Jun 2022
FDA classified: 12 Jul 2022
Reported: 20 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

10 Jun 2022	Recall initiated by company
12 Jul 2022	Classified by FDA	+32 days
20 Jul 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Domestic distribution to the following states: ALASKA ARIZONA CALIFORNIA COLORADO GEORGIA IDAHO IOWA KANSAS KENTUCKY MICHIGAN MINNESOTA MISSOURI NEW YORK NORTH CAROLINA OHIO OKLAHOMA PENNSYLVANIA TENNESSEE

Alaska Arizona California Colorado Georgia Iowa Idaho Kansas Kentucky Michigan Minnesota Missouri North Carolina New York Ohio Oklahoma Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

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

Which lots are affected?

UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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