Hazard

Oxygen Desaturation recalls

8 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 8
Critical: 0
Severe: 5
Most recent: 2026-07-08

Of the 8 oxygen desaturation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (63%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all oxygen desaturation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–8 of 8

SevereFDA (Devices)·Z-2463-2026·2026-07-08
Ventilator breathing circuit sets may obstruct exhalation valve
Hamilton Medical AG is recalling coaxial breathing circuit sets used with three ventilator models because membranes may stick to the expiratory valve body, preventing proper gas exhalation and potentially causing inadequate ventilation.
Product
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1637-2026·2026-04-08
Volara ventilator adapter recalled as Class I over desaturation and barotrauma
Baxter is issuing an urgent correction for the Blue Ventilator Adapter Module used with the Volara system because home users may be unaware of possible oxygen desaturation or lung injury from overexpansion.
Product
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-3262-2024·2024-10-02
Airvo 3 Respiratory Device Recalled for Software Issue Affecting Oxygen Delivery
Fisher & Paykel's Airvo 3 respiratory device has a software defect that may cause it to deliver only room air instead of oxygen during certain alarm conditions, potentially causing oxygen desaturation and hypoxia in patients.
Product
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-1823-2024·2024-05-22
Airvo 2 and myAirvo 2 Humidifiers: Alarm Speaker Defect Recall
Fisher & Paykel's Airvo 2 and myAirvo 2 respiratory humidifiers have a speaker defect that may silence or distort critical alarm sounds. If the alarm fails and therapy is interrupted, patients could experience oxygen desaturation.
Product
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1667-2023·2023-06-21
Nitric Oxide Delivery System check valve misalignment risk
NOxBOXi Nitric Oxide Delivery System devices may malfunction due to misaligned check valves, risking gas leaks and therapy interruption. This could lead to oxygen desaturation if the device fails during patient use.
Product
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2074-2021·2021-07-28
Philips Respironics V60 Plus Ventilator software defect reduces oxygen delivery to patients
Respironics V60 Plus Ventilators (software versions 3.00 and 3.10) may reduce oxygen flow below clinical settings, risking oxygen desaturation and hypoxemia in mechanically ventilated patients.
Product
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2073-2021·2021-07-28
Philips Respironics V60 Ventilator Flow Rate Reduction Safety Defect
Philips Respironics V60 ventilators with High Flow Therapy software versions 3.00 and 3.10 may reduce oxygen delivery below prescribed levels when pressure limits are reached, risking oxygen desaturation.
Product
Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: pat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0788-2020·2020-01-15
Avanos Recalls Haylard Closed Suction Systems Due to Blocked Lumens
Avanos Medical is recalling Haylard Closed Suction Systems for neonates and pediatrics because the central lumen may be blocked, potentially preventing adequate suctioning of airway secretions.
Product
Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; 3. REF 202, Elbow, SAP Finished Product Code 109382903; 4. REF 195-5
Category
Medical Device
Distribution
Distributed nationwide