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 | Ongoing |
| Reason | Increase in premature device failures |
| Product | 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. |
| Quantity | 649 portable suction pumps and replacement pumps |
| Distribution | US Nationwide, including PR. There was government and foreign distribution. There was no military distribution. |
| Initiated | 2021-11-16 |
| Classified | 2022-01-11 |
| Recall number | Z-0482-2022 |
| 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-0482-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88984/
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