The Recall Desk

Hazard

Hypoxemia recalls

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

What the numbers show

Total
13
Critical
1
Severe
11
Most recent
2024-05-29

Of the 13 hypoxemia recalls we have scored against our rubric, 1 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (85%) 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 hypoxemia 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.

1–13 of 13

  • SevereFDA (Devices)·Z-1817-2024·2024-05-29

    Philips OmniLab Advanced + Ventilator May Experience Unexpected Therapy Loss

    Philips OmniLab Advanced + Ventilators may experience an alarm condition that interrupts or stops therapy delivery. This interruption may lead to inadequate breathing support, low oxygen levels, and potentially fatal respiratory failure.

    Product
    OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1814-2024·2024-05-29

    BiPAP A30 Ventilator Recall: Risk of Therapy Interruption and Respiratory Failure

    Philips Respironics BiPAP A30 Ventilators may experience interruption or loss of therapy during a Ventilator Inoperative alarm, potentially causing severe respiratory compromise or death in vulnerable patients.

    Product
    BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1812-2024·2024-05-29

    BiPAP V30 Auto Ventilator May Interrupt Therapy During Malfunction Alarm

    Philips BiPAP V30 Auto Ventilators may interrupt or lose therapy during a Ventilator Inoperative alarm, potentially causing hypoventilation, severe oxygen depletion, or respiratory failure.

    Product
    BiPAP V30 Auto Ventilator, Part Number 1111178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1813-2024·2024-05-29

    BiPAP A40 ventilators risk therapy loss during alarm condition

    BiPAP A40 ventilators may lose therapy delivery during a Ventilator Inoperative alarm, potentially causing respiratory failure or death in vulnerable patients.

    Product
    BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1650-2023·2023-06-14

    Philips Trilogy and LifeVent ventilator models recalled for flow sensor debris

    Environmental debris accumulation may block flow sensors in Philips ventilators, potentially preventing accurate pressure and flow delivery to patients.

    Product
    Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1649-2023·2023-06-14

    Philips Respironics Ventilators Recalled for Flow Sensor Debris Accumulation

    Philips Respironics recalled approximately 57,395 ventilators due to environmental debris potentially accumulating on the flow sensor, which may prevent accurate delivery of pressure and volume to patients, risking hypoxemia.

    Product
    Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1651-2023·2023-06-14

    Trilogy Evo O2 EV300 respiratory devices recalled for debris accumulation

    Philips Respironics recalled 18,855 Trilogy Evo O2 EV300 devices because environmental debris may accumulate on the flow sensor, potentially causing inaccurate delivery of pressure or flow. This could result in patient hypoxemia if not promptly addressed.

    Product
    Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1560-2022·2022-08-31

    Getinge Servo ventilator systems recalled for loss of ventilation

    Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.

    Product
    Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
    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
  • 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-1622-2020·2020-04-08

    Philips V60 Ventilators Recalled for Power Management Board Failure

    Respironics is recalling 23,581 Philips V60 Ventilators because a solder connection failure on the power board may cause the blower to lose power or shut down unexpectedly, potentially leading to hypercarbia or hypoxemia.

    Product
    Philips V60 Ventilators with Power Management PCBA part number 1055906
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-1153-2020·2020-02-19

    Respironics V60 Ventilator User Interface Kits Recalled for Touchscreen Failure

    Respironics is recalling V60 Ventilator User Interface kits because the touchscreen may freeze, preventing clinicians from adjusting therapy settings.

    Product
    Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0008-2015·2014-10-29

    Respironics Esprit Ventilators Recalled for Power Supply Failure Risk

    Respironics is recalling Esprit V1000 and V200 ventilators because a power supply failure may cause loss of ventilator support, potentially leading to hypercarbia or hypoxemia.

    Product
    Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ve
    Category
    Medical Device
    Distribution
    0 states