RegWardenFDA facility compliance records
Recall

Class II — Ohio Medical Corporation

Recalling firmOHIO MEDICAL LLC
Registered facilityOhio Medical LLC (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThe 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.
ProductPortable 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 bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.
Quantity1443 units
DistributionUS Nationwide Distribution and internationally to countries: Canada, Saudi Arabia, and United Arab Emirates.
Initiated2018-08-14
Classified2018-09-07
Terminated2020-12-15
Recall numberZ-2995-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Ohio Medical Corporation (Z-2995-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80785/

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