FDA Medical Device Recalls (openFDA)
O-Two Medical Technologies, Inc.: O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
- Recall number
- Z-2885-2018
- Recalling firm
- O-Two Medical Technologies, Inc.
- Product
- O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
- Status
- Terminated
- Initiated
- 2018-05-14
- Posted
- not on file
- Terminated
- 2020-06-03
- Reason
- Higher levels of nitrous oxide delivered than specification
- Root cause
- Device Design
- Action
- O-Two Medical Technologies Inc. issued letter on May 14. 2018 titled: Notice of Product Upgrade of the 0-Two Equinox Relieve Analgesic Gas Delivery System , requesting customers to return their units for inspection and upgrade. Contact via email to david@otwo.com.
- Quantity
- 3 units
- Distribution
- AK, CA, FL
- Lot, serial or model codes
- Serial Number: EQ1332-17, EQ3001-18, EQ3003-18
- 510(k) numbers
- ["K113687"]
- PMA numbers
- not on file
- Product code
- BZR
- Firm FEI
- 3002807836
- Firm city
- Mississauga
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28