Food, drugs, devices › O-Two Medical Technologies, Inc.
Device recall: O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- I
O-Two Medical Technologies, Inc. (Mississauga) initiated this device recall on 23 Jun 2015; FDA lists 1 product record under event 77528, 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 1 Sep 2017. 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
"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."
Distribution
"Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2705-2017 | 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 | 4382 units (4082 units distributed USA) | Class II | Terminated | 19 Jul 2017 |
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 |
| 14 May 2018 | O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000 | Device | Class II | 1 |
| 30 Sep 2015 | Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 - | 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: "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."
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: "Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Sep 2017. "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.