Food, drugs, devices › O-Two Medical Technologies, Inc.
Device recall: O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
O-Two Medical Technologies, Inc. (Mississauga) initiated this device recall on 14 May 2018; FDA lists 1 product record under event 80414, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 3 Jun 2020. Initiation: voluntary: firm initiated. O-Two Medical Technologies, Inc. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
O-Two Medical Technologies, Inc., Mississauga, Canada.
Reason for recall
"Higher levels of nitrous oxide delivered than specification"
Distribution
"AK, CA, FL"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2885-2018 | O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000 | 3 units | Class II | Terminated | 29 Aug 2018 |
Context
Other enforcement events for O-Two Medical Technologies, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Feb 2019 | e500 Automatic Transport Ventilator, Model Number 01EVE500 | Device | Class I | 3 |
| 30 Sep 2015 | Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 - | Device | Class II | 1 |
| 23 Jun 2015 | O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- I | Device | Class II | 1 |
All 4 events for O-Two Medical Technologies, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Higher levels of nitrous oxide delivered than specification"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "AK, CA, FL"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Jun 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.