GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator… recallZ-1980-2025 · Ohio Medical Corporation · initiated May 8, 2025
Class II Open, Classified All recalls posted in June 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ohio Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
Ohio Medical issued a Field Safety Notice to its consignees on 05/08/2025 followed by telephone calls on 05/13/2025. The notice explained the problem with the device, potential risk, and requested the devices be returned for correction. The notice further stated: "The Field Safety Notice is communicated to all impacted customers and is communicated to competent authorities in the affected markets. Receivers should pass this FSN on to all persons with a need to be advised from within your organization or to any organization where the potentially affected products have been supplied. Please consider end users and others within the supply chain in the circulation of this notice."
Recall details
- Recall number
- Z-1980-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- May 8, 2025
- Posted by the FDA
- Jun 13, 2025
- Recalling firm
- Ohio Medical Corporation
- Quantity
- 36 units
- Product code
- CAW
- FDA submissions
- K162433
- Distribution
- US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.
Product description
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
2 devices cleared under K162433 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- GCE RS-00500Gas Control Equipment Limited · Generator, Oxygen, Portable4 reports
- GCE RS-00600Gas Control Equipment Limited · Generator, Oxygen, Portable2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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