RegWardenFDA facility compliance records
Company

OHIO MEDICAL LLC

4 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2018: 2 recalls; 2021: 1 recalls; 2025: 1 recalls2017220182019202012021202220232024120252026
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-05-08
    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.
  • Class IIOngoing2021-11-16
    Increase in premature device failures
  • Class IITerminated2018-08-14
    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.
  • Class IITerminated2018-03-12
    Final quality control testing was not completed before the devices were distributed..

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “OHIO MEDICAL LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1419185-ohio-medical-llc/

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