Home / Recalls / Ohio Medical Corporation / Z-1980-2025

Z-1980-2025 Class II Ongoing

Recalled by Ohio Medical Corporation — Gurnee, IL

Recall Details

Product Type
Devices
Report Date
June 25, 2025
Initiation Date
May 8, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36 units

Product Description

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

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.

Distribution Pattern

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

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.

Other recalls by Ohio Medical Corporation

  • Z-0482-2022 Class II — Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and In (November 16, 2021)
  • Z-2995-2018 Class II — Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; ( (August 14, 2018)
  • Z-2410-2018 Class II — Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usa (March 12, 2018)