Recall archive / FDA device enforcement
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S — FDA record Z-1980-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 8, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
- 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.
- Classification
- Class II
- Recalling firm
- Ohio Medical Corporation
- Quantity
- 36 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1980-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, ZL322451, ZL322455, ZL322456, ZL322462, ZL322463, ZL322466, ZL322467, ZL322470, ZL322472, ZL322473, ZL322837. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 25, 2025
- Recall initiation date
- May 8, 2025
- Center classification date
- Jun 13, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.