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Recall

Class II — O-Two Medical Technologies, Inc.

Recalling firmO-TWO MEDICAL TECHNOLOGIES, INC.
Registered facilityO-TWO MEDICAL TECHNOLOGIES, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonHigher levels of nitrous oxide delivered than specification
ProductO-Two Equinox® Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
Quantity3 units
DistributionAK, CA, FL
Initiated2018-05-14
Classified2018-08-22
Terminated2020-06-03
Recall numberZ-2885-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — O-Two Medical Technologies, Inc. (Z-2885-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80414/

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