GCE HEALTHCARE Zen-O lite — Class II medical device recall Z-1980-2025
Ongoing recall by Ohio Medical Corporation, reported 2025-06-25, distributed nationwide. Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decre
| Recall number | Z-1980-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ohio Medical Corporation, Gurnee, IL, United States |
| Recall initiated | 2025-05-08 |
| Classified | 2025-06-13 |
| Reported by FDA | 2025-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 36 units |
| Serial numbers | ZL316367, ZL316446, ZL316462, ZL316475, ZL316481, ZL316484, ZL316490, ZL316493, ZL316503, ZL317057, ZL317087, ZL317088, ZL317090, ZL322386, ZL322387, ZL322390, ZL322392, ZL322409, ZL322412, ZL322439, ZL322441, ZL322442, ZL322443, ZL322445, ZL322447 and 11 more |
| Model numbers | RS-00608-X-S |
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.
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-1980-2025. 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.