Facility

O-TWO MEDICAL TECHNOLOGIES, INC.

4 recall(s) on record — most severe on record: Class I.

Key facts

4recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002807836
Establishment type	Manufacture Medical Device
Location	45A Armthorpe Road Brampton Ontario, CA L6T 5M4
Registration status	Active · expires 2026
Parent company	O-TWO MEDICAL TECHNOLOGIES, INC. (owner-operator 8020332)
Brand names	O-TWO DISPOSABLE VENTILATION CIRCUIT; O-TWO REUSABLE VENTILATION CIRCUIT

Activity by year

Recalls (4)

Devices registered here (1)

Circuit, Breathing (W Connector, Adaptor, Y Piece)
Product code CAI (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5240

Recalls & enforcement

Class ITerminated2019-02-12
There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the …
Class IITerminated2018-05-14
Higher levels of nitrous oxide delivered than specification
Class IITerminated2015-09-30
For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches of Burn Relief® products to prevent potential contamination. .
Class IITerminated2015-06-23
Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.

All facilities operated by O-TWO MEDICAL TECHNOLOGIES, INC.

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

Cite this record

RegWarden. “O-TWO MEDICAL TECHNOLOGIES, INC. (FEI 3002807836) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807836-o-two-medical-technologies-inc/

Not open yet

Alerts for O-TWO MEDICAL TECHNOLOGIES, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.