Class I — O-Two Medical Technologies, Inc.
| Recalling firm | O-TWO MEDICAL TECHNOLOGIES, INC. |
|---|---|
| Registered facility | O-TWO MEDICAL TECHNOLOGIES, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit. |
| Product | e500 Automatic Transport Ventilator, Model Number 01EVE500 |
| Quantity | 136 |
| Distribution | The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA. |
| Initiated | 2019-02-12 |
| Classified | 2019-04-04 |
| Terminated | 2023-06-29 |
| Recall number | Z-0976-2019 |
| 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 I recall — O-Two Medical Technologies, Inc. (Z-0976-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82178/
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