Invacare Platinum 5NXG Oxygen Concentrator — Class III medical device recall Z-1369-2022
Ongoing recall by Invacare Corporation, reported 2022-07-20, distributed in AK, AZ, CA, CO, GA, IA, ID, KS…. Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only
| Recall number | Z-1369-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invacare Corporation, Elyria, OH, United States |
| Recall initiated | 2022-06-10 |
| Classified | 2022-07-12 |
| Reported by FDA | 2022-07-20 |
| Distributed | AK, AZ, CA, CO, GA, IA, ID, KS, KY, MI, MN, MO, NC, NY, OH, OK, PA, TN |
| Quantity | 179 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00841447112075 |
| Model numbers | P5NXG1, P5NXGC1 |
Product
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1369-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.