Ohio Medical Corporation: Medical Device Recall in 2025 - (Recall #: Z-1980-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 8, 2025

Date Posted: June 25, 2025

Recall Number: Z-1980-2025

Event ID: 96851

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.

Status: Ongoing

Product Quantity: 36 units

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated