O-Two Adult Ventilation Timer Recalled Due to Flash Rate Malfunction
O-Two Medical Technologies is recalling Adult Ventilation Timers because the flash rate may be twice the labeled rate, potentially affecting ventilation guidance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device malfunction that could lead to incorrect clinical guidance (ventilation rate), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
O-Two Medical Technologies, Inc. is recalling the O-Two Adult Ventilation Timer, models 01BM1000-CS, 01BM3201-MOTP-CS, and 01BM3201-MOTL-CS. The recall involves 4,382 units, of which 4,082 were distributed in the United States. The devices were distributed nationwide in the US, as well as in Canada, Denmark, and Finland.
The recall was initiated due to a malfunction where the flash rate of the device was reported to be twice the rate noted on the label. The Adult Ventilation Timer is intended to guide rescuers to provide ventilations at a rate appropriate for adult patients. A discrepancy in the flash rate could result in incorrect ventilation guidance.
Affected units include lot numbers 079810, 078734, 081071, 140411, 141117, 140719, 140506, and 130117, with an expiration date of July 2016. Users should stop using the affected devices and contact O-Two Medical Technologies for further instructions.
The recalled product
- 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
- Manufacturer
- O-Two Medical Technologies, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #s: 079810
- 078734
- 081071
- 140411
- 141117
- 140719
- 140506
- 130117 Expiration date: Jul.2016
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · O-Two Medical Technologies, Inc.
See all →- SevereO-Two Medical e700 Ventilator Recalled for Fire Risk
FDA (Devices) · 2019-04-10
- SevereO-Two Medical e500 Ventilator Recalled for Fire Hazard
FDA (Devices) · 2019-04-10
- CriticalO-Two Medical e600 Ventilator Recalled for Fire Risk
FDA (Devices) · 2019-04-10
- HighO-Two Equinox Relieve Gas System Recalled for High Nitrous Oxide Levels
FDA (Devices) · 2018-08-29
- HighO-Two Medical Recalls Burn Relief Dressings Due to Sterilization Concerns
FDA (Devices) · 2017-07-19
Same hazard · malfunction
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- High
- ModeratePhilips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue
FDA (Devices) · 2026-06-10
- SevereElectric Start Pressure Washers Recalled for Carbon Monoxide Hazard
CPSC · 2026-05-14