CLASS II ONGOING Device recall · Reported 25 Jun 2025 · FDA Enforcement Report

GCE Healthcare Zen-O lite, Portable Oxygen Concentrator recalled

Ohio Medical is recalling GCE Healthcare Zen-O lite, Portable Oxygen Concentrator, distributed nationwide in the US. The recall was initiated on 8 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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.

Quantity recalled36 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1980-2025
FDA event ID: 96851
Recalling firm: Ohio Medical, Gurnee, IL
Classification: Class II
Status: Ongoing
Recall initiated: 8 May 2025
FDA classified: 13 Jun 2025
Reported: 25 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

8 May 2025	Recall initiated by company
13 Jun 2025	Classified by FDA	+36 days
25 Jun 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

Where it was distributed

US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.

Nationwide Arkansas California Florida Kentucky Minnesota Mississippi North Dakota Nevada Virginia

Questions about this recall

Why was it 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.

Which lots are affected?

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.

Where was it sold?

US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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