Data Foundry

Medical device recalls 2018

O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery… — Class II medical device recall Z-2885-2018

Terminated recall by O-Two Medical Technologies, Inc., reported 2018-08-29, distributed in AK, CA, FL. Higher levels of nitrous oxide delivered than specification

Recall numberZ-2885-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmO-Two Medical Technologies, Inc., Mississauga, Canada
Recall initiated2018-05-14
Classified2018-08-22
Reported by FDA2018-08-29
Terminated2020-06-03
DistributedAK, CA, FL
Quantity3 units
Serial numbersEQ1332-17, EQ3001-18, EQ3003-18
Model numbers01EQ1000

Product

O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

Reason for recall

Higher levels of nitrous oxide delivered than specification

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2885-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.