# FDA recall Z-1369-2022

> **Invacare Corporation** · Class III · device recall initiated 2022-06-10.

## 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.

## 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

## Key facts

- **Recall number:** Z-1369-2022
- **Recalling firm:** Invacare Corporation
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-10
- **Report date:** 2022-07-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elyria, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2022

## Citation

> AI Analytics. FDA recall Z-1369-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1369-2022. Source: US FDA. Licensed CC0.

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