Invacare Platinum 5NXG Oxygen Concentrator Recall: Missing Rx Only Label
Invacare recalls specific Canada models of oxygen concentrators due to missing 'Rx Only' label on product labels produced between March 2021 and December 2021. Affected units have serial number prefixes starting with 21F, 21J, 21G, 21K, 21H, or 21L.
Lower-risk recall
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Contact the company
What happened, in plain English
Invacare is recalling certain Canada-specific oxygen concentrators because the product labels produced between March 2021 and December 2021 did not include the required 'Rx Only' statement. This could lead to improper use if the device is not prescribed by a healthcare provider. Read more at govinfonow.com/recall/60514-invacare-platinum-5nxg-oxygen-concentrator-recall-missing-rx-only-label.
Source Summary by GovInfoNow · govinfonow.com/recall/60514-invacare-platinum-5nxg-oxygen-concentrator-recall-missing-rx-only-label · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1369-2022
Cite this page
“Invacare Platinum 5NXG Oxygen Concentrator Recall: Missing Rx Only Label.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60514-invacare-platinum-5nxg-oxygen-concentrator-recall-missing-rx-only-label. Based on FDA recall #Z-1369-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1369-2022%22&limit=1).
Why it’s dangerous
The product label did not contain the required 'Rx Only' statement as mandated by regulations. This means the device might be used by individuals who are not prescribed for it, potentially leading to unsafe medical use.
Who’s affected
People in Canada who own or use the Invacare Platinum 5NXG Oxygen Concentrator with model numbers P5NXG1 or P5NXGC1 are affected. Those who have the specific serial number prefixes listed are most at risk.
How to tell if you have this one
Check for the model numbers P5NXG1 or P5NXGC1 on the device. Look for serial number prefixes starting with 21F, 21J, 21G, 21K, 21H, or 21L. These units were produced between March 2021 and December 2021 in Canada.
- Brand
Invacare- Category
Medical device
What to do — step by step
Check Product Label
Verify the model number and serial number prefixes to confirm if the device is affected.
Where it went and when
Where it was distributed
Distributed in 18 states.
FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alaska, Arizona, California, Colorado, Georgia, Idaho, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1369-2022 (June 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1369-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.