Class II — 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 II |
| Status | Terminated |
| Reason | Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label. |
| Product | O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients |
| Quantity | 4382 units (4082 units distributed USA) |
| Distribution | Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland |
| Initiated | 2015-06-23 |
| Classified | 2017-07-10 |
| Terminated | 2017-09-01 |
| Recall number | Z-2705-2017 |
| 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 — O-Two Medical Technologies, Inc. (Z-2705-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77528/
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