FDA Medical Device Recalls (openFDA)
Invacare Corporation: Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
- Recall number
- Z-1369-2022
- Recalling firm
- Invacare Corporation
- Product
- Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
- Status
- Open, Classified
- Initiated
- 2022-06-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
- Root cause
- Labeling Change Control
- Action
- 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.
- Quantity
- 179 devices
- 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
- Lot, serial or model codes
- UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX
- 510(k) numbers
- ["K203210"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 1525712
- Firm city
- Elyria
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28