The Recall Desk

Hazard

Hypoxia recalls

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

What the numbers show

Total
54
Critical
16
Severe
19
Most recent
2026-06-24

Of the 54 hypoxia recalls we have scored against our rubric, 16 (30%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (35%) 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 hypoxia 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.

26–50 of 54

  • 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
  • SevereFDA (Devices)·Z-2020-2024·2024-06-26

    Ventilator HAMILTON-C6 may fail to restart, risking oxygen deprivation

    Hamilton Medical AG is recalling the HAMILTON-C6 ventilator due to a sensor failure that may prevent re-initiation after reconnection, potentially causing hypoxia.

    Product
    Ventilator HAMILTON-C6, PN: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1064-2024·2024-03-06

    AirLife Manual Resuscitator Recall Due to Broken Components Preventing Ventilation

    Vyaire Medical is recalling 1,020,330 AirLife Adult Manual Resuscitators due to defective components that can fail to deliver proper ventilation. When components break or disassemble, users may experience hypoventilation or hypoxia, potentially fatal complications.

    Product
    AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1063-2024·2024-03-06

    AirLife Adult Manual Resuscitator recalled for ventilation failure risk

    Vyaire Medical is recalling 4,572 units of AirLife Adult Manual Resuscitators due to defective components that may cause improper ventilation or complete ventilation failure, potentially resulting in hypoventilation, hypoxia, or death.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1057-2024·2024-03-06

    AirLife Adult Manual Resuscitator units recalled for component failure

    Vyaire Medical is recalling 106,656 units of AirLife Adult Manual Resuscitator bags due to faulty components that may break during use, causing ventilation failure and potentially leading to hypoxia or death.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1065-2024·2024-03-06

    AirLife Manual Resuscitator recalled for broken components causing ventilation failure

    Vyaire Medical is recalling approximately 1.8 million AirLife Adult Manual Resuscitators worldwide due to faulty molded components that may fail to deliver proper ventilation, risking hypoventilation and hypoxia.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1059-2024·2024-03-06

    AirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure

    Vyaire Medical is recalling 8,220 AirLife Adult Manual Resuscitators with defective duckbill and ring components. The manufacturing defect may prevent proper ventilation and could lead to hypoxia or death.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1062-2024·2024-03-06

    AirLife manual resuscitator component defect risks ventilation failure

    Vyaire Medical is recalling AirLife Adult Manual Resuscitators with defective duckbill and ring components that may fail to provide ventilation, risking hypoventilation or hypoxia. The defect affects units manufactured in 2017 and earlier.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1061-2024·2024-03-06

    AirLife Adult Manual Resuscitator Recalled for Ventilation Failure Risk

    Vyaire Medical recalls 3.6 million AirLife Adult Manual Resuscitators due to defective oxygen tubing components that may fail to deliver proper ventilation, risking hypoxia. Affected units were manufactured in 2017 or earlier.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1060-2024·2024-03-06

    AirLife Adult Manual Resuscitator Kits Recalled for Component Failure

    Vyaire Medical is recalling 3,636 AirLife Adult Manual Resuscitator kits. Manufacturing defects can cause component failure that prevents proper ventilation, potentially resulting in fatal hypoxia.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1058-2024·2024-03-06

    AirLife Adult Manual Resuscitator tubing may fail to deliver proper ventilation

    Vyaire Medical is recalling 66,078 units of AirLife Adult Manual Resuscitator oxygen tubing worldwide due to component manufacturing defects that can cause device failure and inadequate ventilation.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0420-2024·2023-12-13

    CARDIOHELP Emergency Drive Blockage May Impair Cardiac Blood Oxygenation

    The FDA is recalling CARDIOHELP Emergency Drive units due to potential blocking that impairs blood flow. Affected patients may experience ischemia and hypoxia from inappropriate low blood oxygen.

    Product
    CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2024·2023-11-29

    Medline Manual Resuscitators Recalled for Backwards Manometer Leak

    Medline manual resuscitators are recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. The defect affects multiple models used in respiratory care distributed nationwide.

    Product
    Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM1116PMT, CPRM1126FM, CPRM1126FPM, CPRM1126FPWM, CPRM1126M; 2. Infant Resus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1139-2023·2023-03-08

    Life2000 Ventilator System Recall: Risk of Patient Desaturation

    Baxter Healthcare is recalling 4,279 Life2000 Ventilator Systems due to potential patient desaturation when connected to oxygen concentrators.

    Product
    Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1141-2023·2023-03-08

    Life2000 Hospital Ventilator Recalled for Patient Desaturation Risk

    Baxter Healthcare is recalling 8 Life2000 Hospital Ventilator systems due to potential patient desaturation events when the device is connected to an oxygen concentrator.

    Product
    Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0961-2023·2023-02-01

    Getinge Flow-e Anesthesia System Software Defect Prevents Patient Ventilation

    Getinge Flow-e Anesthesia System units with certain software versions contain a bug that can prevent pressure buildup and ventilation delivery. This may result in inadequate oxygen delivery and hypoxia in anesthesia patients.

    Product
    Getinge Flow-e Anesthesia System, Part No. 6887900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2023·2022-12-14

    2.5 mm LifePort Endotracheal Tube Adapters Deformation Risk

    Bunnell's 2.5 mm LifePort Endotracheal Tube Adapters may deform due to improper packaging, potentially affecting ventilator performance. The defect may lead to hypercarbia, hypoxia, and gas trapping.

    Product
    2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0059-2021·2020-10-14

    AB ULAX 1500 Flex Heat and Moisture Exchanger Recall for Disconnection Risk

    AB ULAX is recalling 1500 Flex Heat and Moisture Exchangers because they may disconnect from the respiratory circuit, potentially causing hypoxia or death.

    Product
    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2537-2020·2020-07-15

    Vitalconnect VistaSolution Software Recall for Missing SpO2 Notifications

    Vitalconnect Inc. is recalling VistaSolution software due to a defect that prevented low SpO2 alerts, potentially exposing patients to short-term hypoxia.

    Product
    VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0813-2020·2020-01-29

    GE Healthcare Recalls Carestation Anesthesia Systems Due to Loose Cable Connection

    GE Healthcare is recalling 3,319 Carestation anesthesia systems worldwide due to a potential loose cable connection that could cause loss of mechanical ventilation.

    Product
    Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2020·2020-01-29

    GE Healthcare Recalls Carestation Anesthesia Systems Due to Loose Cable Risk

    GE Healthcare is recalling 280 Carestation anesthesia systems worldwide due to a potential loose cable connection that could cause a loss of mechanical ventilation.

    Product
    Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0463-2019·2018-12-12

    GE Healthcare Recalls CARESCAPE R860 Inspiratory Safety Guards

    GE Healthcare is recalling CARESCAPE R860 Inspiratory Safety Guards because they may disconnect from the breathing circuit, potentially causing loss of ventilation and hypoxia in patients.

    Product
    GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2954-2018·2018-09-05

    GE Carestation Anesthesia Systems Recalled for Gas Switch Defect

    GE Medical Systems is recalling 310 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.

    Product
    GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2955-2018·2018-09-05

    GE Carestation 30 Anesthesia Systems Recalled for Gas Switch Defect

    GE Medical Systems is recalling 252 Carestation 30 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.

    Product
    GE Carestation 30 anesthesia systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2956-2018·2018-09-05

    GE 9100c NXT anesthesia systems recalled for gas switch defect

    GE Medical Systems is recalling 401 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.

    Product
    GE 9100c NXT anesthesia systems
    Category
    Medical Device
    Distribution
    0 states