Public recall detail

FreeO2 Automated Oxygen Therapy Device Adult & Pediatric - Version HW 2.3

2026-10-08

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Health products Health product recall
Quick summary

Quick summary: FreeO2 Automated Oxygen Therapy Device Adult & Pediatric - Version HW 2.3. Reason: Health product recall. Category: Health products. Date: 2026-10-08.

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 - Version HW 2.3. Reason: Health product recall. Category: Health products. Date: 2026-10-08.

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 - Version HW 2.3
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82749

Affected products

ProductFreeO2 Automated Oxygen Therapy Device Adult & Pediatric
LotVersion HW 2.3
ModelFO2-110-00
Serial numberVersion HW 2.3
DescriptionFreeO2 Automated Oxygen Therapy Device Adult & Pediatric

Issue

Under specific conditions following a deep battery discharge, error 29515 may occur during startup of a FreeO2 HW 2.3 device using software package 1.4.2 and prevent its use. The update to software package 1.4.3 corrects this issue and restores the expected startup behaviour.

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 date2026-09-30
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82749
Background{}
CompaniesOxynov, Inc. 725, Boulevard Lebourgneuf, Quebec, Quebec, Canada, G2J 0C4
AudiencesHealthcare
Source updated2026-10-08

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

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