O-Two Equinox Relieve Gas System Recalled for High Nitrous Oxide Levels
O-Two Medical Technologies is recalling three Equinox Relieve gas systems because they may deliver higher levels of nitrous oxide than specified.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II and involves a risk-of-harm product (excessive gas delivery) where specific injury reports are not detailed in the source text, fitting the High severity criteria.
Plain-English summary
O-Two Medical Technologies, Inc. is recalling three units of the O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System, Model 01EQ1000. The recall was initiated because the devices may deliver higher levels of nitrous oxide than the specified requirements.
The affected units have serial numbers EQ1332-17, EQ3001-18, and EQ3003-18. These devices were distributed in Alaska, California, and Florida.
The U.S. Food and Drug Administration has classified this recall as Class II. Users should contact O-Two Medical Technologies for further instructions on how to address the issue.
The recalled product
- Product
- O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
- Manufacturer
- O-Two Medical Technologies, Inc.
- Hazard
- Affected units
- 3
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 (3)
- Serial Number: EQ1332-17
- EQ3001-18
- EQ3003-18
Distribution
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 Adult Ventilation Timer Recalled Due to Flash Rate Malfunction
FDA (Devices) · 2017-07-19
- HighO-Two Medical Recalls Burn Relief Dressings Due to Sterilization Concerns
FDA (Devices) · 2017-07-19
Similar recalls
- HighCAREstream ProNox Nitrous Oxide Delivery Systems Recalled for High Gas Levels
FDA (Devices) · 2018-08-29
- HighINOmax DSIR Nitric Oxide System Recalled for Monitoring Error
FDA (Devices) · 2014-12-17
- HighINOmax DSIR Nitric Oxide Delivery System Recalled for Monitoring Anomaly
FDA (Devices) · 2014-05-14
- ModerateNitric oxide delivery systems recalled to replace sample pumps failing at high rates
FDA (Devices) · 2025-09-17
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
- CriticalNitric oxide delivery systems recalled over dose fluctuations at low flow
FDA (Devices) · 2025-10-15