Public recall detail

FreeO2 Automated Oxygen Therapy Device Adult & Pediatric

2026-10-06

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Health products Health product recall
Quick summary

Quick summary: FreeO2 Automated Oxygen Therapy Device Adult & Pediatric. Reason: Health product recall. Category: Health products. Date: 2026-10-06.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: FreeO2 Automated Oxygen Therapy Device Adult & Pediatric. Reason: Health product recall. Category: Health products. Date: 2026-10-06.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandOxynov, Inc.
ProductFreeO2 Automated Oxygen Therapy Device Adult & Pediatric
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82735

Affected products

ProductFreeO2 Automated Oxygen Therapy Device Adult & Pediatric
LotVersion HW 1.2
ModelFO2-110-00
Serial numberVersion HW 1.2
DescriptionFreeO2 Automated Oxygen Therapy Device Adult & Pediatric

Issue

A battery reading error may occur when certain Freeo2 HW 1.2 devices are restarted following an upgrade from software version 1.2.X to 1.4.X. The error is immediately detectable, prevents the device from being returned to service and requires installation of a resistor at position R39.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesOxynov, Inc. 725, Boulevard Lebourgneuf, Quebec, Quebec, Canada, G2J 0C4
Recall date2026-09-22
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82735
Background{}
CompaniesOxynov, Inc. 725, Boulevard Lebourgneuf, Quebec, Quebec, Canada, G2J 0C4
AudiencesHealthcare
Source updated2026-10-06

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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