Ohio Medical Corporation: Device Recall
Recall #Z-1980-2025 · 05/08/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1980-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Ohio Medical Corporation
- Status
- Ongoing
- Date Initiated
- 05/08/2025
- Location
- Gurnee, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units
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.
Product Description
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Distribution Pattern
US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.