GCE HEALTHCARE Zen-O lite Oxygen Concentrator Recall: Erroneous Calibration Risk
GCE HEALTHCARE Zen-O lite portable oxygen concentrators with specific serial numbers have erroneous calibration that may cause inaccurate low oxygen purity alarms as the device ages.
Lower-risk 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.
Contact the company
What happened, in plain English
Ohio Medical Corporation is recalling GCE HEALTHCARE Zen-O lite portable oxygen concentrators with certain serial numbers due to potential calibration errors. This could cause the device to give incorrect low oxygen purity alarms as the units age, which might lead to unsafe oxygen levels for users. Read more at govinfonow.com/recall/52322-gce-healthcare-zen-o-lite-oxygen-concentrator-recall-erroneous-calibration.
Source Summary by GovInfoNow · govinfonow.com/recall/52322-gce-healthcare-zen-o-lite-oxygen-concentrator-recall-erroneous-calibration · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1980-2025
Cite this page
“GCE HEALTHCARE Zen-O lite Oxygen Concentrator Recall: Erroneous Calibration Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52322-gce-healthcare-zen-o-lite-oxygen-concentrator-recall-erroneous-calibration. Based on FDA recall #Z-1980-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1980-2025%22&limit=1).
Why it’s dangerous
The device may develop calibration errors over time, causing it to incorrectly signal low oxygen purity when the actual oxygen levels are safe. This could lead to users not knowing when their oxygen levels are dangerously low.
Who’s affected
Patients using the recalled Zen-O lite oxygen concentrators with specific serial numbers are most at risk. The recall affects individuals who rely on this portable oxygen device for medical treatment.
How to tell if you have this one
Check for the model number RS-00608-X-S and the specific serial numbers listed in the recall notice. The affected units have serial numbers starting with ZL316367 through ZL322473.
- Brand
GCE HEALTHCARE- Category
Medical device
What to do — step by step
Check Serial Numbers
Verify your device's serial number against the list of affected numbers provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
FDA distribution: “US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Florida, Kentucky, Minnesota, Mississippi, Nevada, North Dakota, Virginia.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1980-2025 (May 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1980-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.