O-Two Medical Technologies, Inc.
O-Two Medical Technologies, Inc. has 4 FDA enforcement events on this register (6 product records) between 2015 and 2019: 4 device; the busiest year was 2015 with 2.
25% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in Ontario.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 12 Feb 2019 | e500 Automatic Transport Ventilator, Model Number 01EVE500 | Device | Class I | 3 | Terminated |
| 14 May 2018 | O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000 | Device | Class II | 1 | Terminated |
| 30 Sep 2015 | Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns. | Device | Class II | 1 | Terminated |
| 23 Jun 2015 | 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 | Device | Class II | 1 | Terminated |
By type and class
Class I: 25% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has O-Two Medical Technologies, Inc. had?
4 enforcement events (6 product records) on this register, 2015–2019: 4 device.
Are any O-Two Medical Technologies, Inc. recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are O-Two Medical Technologies, Inc. recalls?
3 Class II, 1 Class I. 25% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.