Gurnee, IL, United States
Ohio Medical Corporation recalls
4 recalls recorded since 2018, most recently on 8 May 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 May 2025
- Reason
- 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
- US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1980-2025
- GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Ongoing Class II Medical devices
- Recall started
- 16 November 2021
- Reason
- Increase in premature device failures
- Distribution
- US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0482-2022
- Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.
Terminated Class II Medical devices
- Recall started
- 14 August 2018
- Terminated
- 15 December 2020
- Reason
- The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.
- Distribution
- US Nationwide Distribution and internationally to countries: Canada, Saudi Arabia, and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2995-2018
- Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign
Terminated Class II Medical devices
- Recall started
- 12 March 2018
- Terminated
- 16 July 2020
- Reason
- Final quality control testing was not completed before the devices were distributed..
- Distribution
- US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2410-2018
- Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.