O-Two Medical Technologies, Inc.: FDA recalls
FDA enforcement events from 2015 to 2019; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.
FDA enforcement reports name O-Two Medical Technologies, Inc. as the recalling firm in 4 events. The events have 6 product records. The recalls started from 2015 to 2019. All the events are device recalls. By FDA enforcement events, O-Two Medical Technologies, Inc. is number 831 of 1,628 firms that have a page. Events that O-Two Medical Technologies, Inc. started: none in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Enforcement events
4 events, newest first.
| 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 |
An event with 1 product record and a class that is not Class I has no page. It has a row in this table.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Recalling firm: The firm that the FDA record names for a recall.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Type and class
| Type | Events |
|---|---|
| Device | 4 |
| Class | Events |
|---|---|
| Class II | 3 |
| Class I | 1 |
- Share of the events of the firm in Class I
- 25%
- Share of all events on the register in Class I
- 18%
- Events with the status Ongoing
- 0
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Events by year
Official channels
- FDA enforcement reportsThe FDA search of the weekly enforcement reports.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Cite this page
Recall Register. O-Two Medical Technologies, Inc.: FDA recalls. https://recallregister.com/firm/o-two-medical-technologies-inc/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA enforcement reports
- Licence
- CC0 1.0
- Export date
- 3 Nov 2026
- State of the firm address
- Ontario
The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.
A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.
Questions
- Which classes do the FDA recalls of O-Two Medical Technologies, Inc. have?
- Class II: 3 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
- What is the newest FDA recall of O-Two Medical Technologies, Inc.?
- FDA event 82178, which the firm started on 12 Feb 2019. The first product in the record is:
e500 Automatic Transport Ventilator, Model Number 01EVE500
- How many FDA recalls of O-Two Medical Technologies, Inc. have the status Ongoing?
- No event has the status Ongoing in the openFDA file. openFDA says about the status:
FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.