Invacare Corporation Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Brand
Invacare Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX
Invacare Corporation is recalling Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) due to Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Recommended Action
Per FDA guidance
On June 10, 2022, the firm distributed Medical Device Correction letters to affected providers. Providers were informed that they may have received product with an incorrect label which does not contain the required "Rx Only" symbol. Providers were provided with Provider Acknowledgement Cards which included instructions for applying the correct product label to the device. Providers are responsible for ensuring that the field correction is conducted with their customers. If you have any questions concerning these instructions, please call Invacare's field correction support line at (877) 413-6008 (U.S. Customers) Monday thru Friday, 8 a.m. 5 p.m. EST, for assistance.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, AZ, CA, CO, GA, ID, IA, KS, KY, MI, MN, MO, NY, NC, OH, OK, PA, TN
Page updated: Jan 10, 2026