Z-2885-2018Class II

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

Name: Z-2885-2018 O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
Creator: O-Two Medical Technologies, Inc.
Published: 2018-05-14
License: https://open.fda.gov/license/

O-Two Medical Technologies, Inc. / initiated 2018-05-14 / Terminated / root cause: design

FDA source

O-Two Medical Technologies, Inc. began a recall of O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000 on 2018-05-14. FDA classified it as Class II and gives the reason as "Higher levels of nitrous oxide delivered than specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2885-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-14
Posted: 2018-08-22
Terminated: 2020-06-03
Recalling firm: O-Two Medical Technologies, Inc.
Product: O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
Product code: BZR Mixer, Breathing Gases, Anesthesia Inhalation
Reason for recall: Higher levels of nitrous oxide delivered than specification
Root cause tag: design
FDA 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 [email protected].
Quantity in commerce: 3 units
Distribution: AK, CA, FL
Product codes and lots: Serial Number: EQ1332-17, EQ3001-18, EQ3003-18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2885-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2885-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-22

Product code BZR

K113687Class IIEquinox RelieveO-Two Medical Technologies, Inc. / cleared 2012-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)