Class II — Ohio Medical Corporation
| Recalling firm | OHIO MEDICAL LLC |
|---|---|
| Registered facility | Ohio Medical LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 | GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S |
| Quantity | 36 units |
| Distribution | US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY. |
| Initiated | 2025-05-08 |
| Classified | 2025-06-13 |
| Recall number | Z-1980-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ohio Medical Corporation (Z-1980-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96851/
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