# FDA recall Z-1980-2025

> **Ohio Medical Corporation** · Class II · device recall initiated 2025-05-08.

## Product

GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

## Reason for recall

Erroneous calibration values, potentially resulting in:  as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.

## Distribution

US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.

## Key facts

- **Recall number:** Z-1980-2025
- **Recalling firm:** Ohio Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-08
- **Report date:** 2025-06-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gurnee, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1980-2025

## Citation

> AI Analytics. FDA recall Z-1980-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1980-2025. Source: US FDA. Licensed CC0.

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