Class II — Ohio Medical Corporation
| Recalling firm | OHIO MEDICAL LLC |
|---|---|
| Registered facility | Ohio Medical LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Final quality control testing was not completed before the devices were distributed.. |
| Product | 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. |
| Quantity | 11 units |
| Distribution | US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL. |
| Initiated | 2018-03-12 |
| Classified | 2018-07-10 |
| Terminated | 2020-07-16 |
| Recall number | Z-2410-2018 |
| Initiation | Voluntary: 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-2410-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80294/
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