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.
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 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
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