Reported Jun 25, 2025 · Ongoing
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Ohio Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ohio Medical Corporation · 1111 Lakeside Dr · Gurnee, IL · 60031-2489
Is this the product you have?
- GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
- Lot codes and dates
- Serial Numbers
ZL316367ZL316446ZL316462ZL316475ZL316481ZL316484ZL316490ZL316493ZL316503ZL317057ZL317087ZL317088ZL317090ZL322386ZL322387ZL322390ZL322392ZL322409ZL322412ZL322439ZL322441ZL322442ZL322443ZL322445ZL322447ZL322451ZL322455ZL322456ZL322462ZL322463ZL322466ZL322467ZL322470ZL322472ZL322473ZL322837
- Serial Numbers
- Amount recalled
- 36 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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