The Recall Desk

Hazard

Sensor Malfunction recalls

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

What the numbers show

Total
55
Critical
1
Severe
11
Most recent
2026-07-22

Of the 55 sensor malfunction recalls we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (20%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sensor malfunction 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.

1–25 of 55

  • ModerateFDA (Devices)·Z-2743-2026·2026-07-22

    Photera 600 Phototherapy Device UV Sensor Calibration Error

    Daavlin Distributing Company is recalling 26 Photera 600 phototherapy devices nationwide because the UV sensor gain calibration is incorrect, causing inaccurate ultraviolet output readings.

    Product
    Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2744-2026·2026-07-22

    Photera 600 3-D phototherapy device UV sensor calibration error recall

    Daavlin Distributing Company is recalling Photera 600 3-D phototherapy devices because the UV sensor gain calculation is incorrect, causing inaccurate ultraviolet output measurement.

    Product
    Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1996-2026·2026-05-06

    iLet Bionic Pancreas Software Versions Recalled for Delayed CGM Readings

    Beta Bionics is recalling iLet Bionic Pancreas units with software versions 1.4.2 and 1.4.3 due to a compatibility issue with Dexcom G7 sensors that can cause delayed glucose readings and loss of automatic insulin adjustments.

    Product
    iLet Bionic Pancreas, REF: BB1001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1469-2026·2026-03-11

    Abiomed Impella RP with SmartAssist recalled as Class I

    Abiomed is recalling the Impella RP with SmartAssist because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.

    Product
    Impella RP with SmartAssist. Product Code: 0046-0035.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1471-2026·2026-03-11

    Abiomed Impella RP recalled as Class I over sensor malfunction risk

    Abiomed is recalling the Impella RP, product code 0046-0011, because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.

    Product
    Impella RP. Product Code: 0046-0011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1470-2026·2026-03-11

    Abiomed Impella RP Flex recalled as Class I over sensor drift

    Abiomed is recalling the Impella RP Flex with SmartAssist because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.

    Product
    Impella RP Flex with SmartAssist. Product Code: 1000323.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0831-2025·2025-01-22

    Dialysis Blood Circuit May Cause Excessive Fluid Removal

    The AquaFlexFlow UF 500 Plus blood circuit may malfunction and remove excessive fluid from patients, causing a dangerous drop in blood volume. This risk is especially dangerous for pediatric patients.

    Product
    nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0295-2025·2024-11-20

    Ventilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure

    Philips Respironics is recalling 1,322 Garbin Evo ventilators (Model LD2110X23B) worldwide due to potential aerosol accumulation that could cause inaccurate flow sensor readings, posing a risk to patient care.

    Product
    Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V510000·2024-07-03

    Front airbag deployment defect in 2019 Alfa Romeo Stelvio

    Chrysler is recalling 2019 Alfa Romeo Stelvio vehicles for a defective seat belt buckle switch sensor that may prevent front airbags from deploying. Dealers will repair the connection at no cost.

    Product
    ALFA ROMEO — ALFA ROMEO, FIAT, JEEP STELVIO, GIULIA, 500E, 500X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2024·2024-05-08

    Medtronic Invos Sensor Cable Recalled for Manufacturing Defects

    Covidien is recalling 2,305 units of the Medtronic Invos Reusable Sensor Cable (PMAC71RSC) due to manufacturing defects in sensor cable connectors that may cause error codes or device malfunction.

    Product
    Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-1520-2024·2024-04-24

    SonarMed Airway Monitoring Sensor Fails to Detect Partial Obstruction

    SonarMed Inc is recalling 690 units of the AW-S030 NEO SONARMED SENSOR because the sensor fails to detect partial airway obstruction. The devices were distributed across 20 US states.

    Product
    AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1005-2024·2024-02-14

    Medical Device Recall: Guardian 4 Glucose Sensor Manufacturing Defect

    Medtronic is recalling Guardian 4 Glucose Sensors due to manufacturing defects in the glucose oxidase layer. Defects may cause sensors to malfunction or provide inaccurate readings, potentially affecting insulin dosing.

    Product
    Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2269-2023·2023-08-09

    SPiN Xtend Instruments Recalled for Electromagnetic Sensor Tracking Malfunction

    Olympus Corporation is recalling 144 units of SPiN Xtend 2.0mm OD instruments (Model INS-5450) due to electromagnetic sensor tracking malfunction that impairs navigation during endobronchial procedures and may cause procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-5450
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2264-2023·2023-08-09

    Olympus SPiN Drive Forceps Recalled for EM Sensor Malfunction

    Olympus SPiN Drive Forceps are being recalled due to an electromagnetic sensor malfunction that disables navigation functionality during endobronchial procedures, potentially causing procedural delays. No injuries reported.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2023·2023-08-09

    SPiN Drive Needle Navigation Sensor Malfunction Triggers Procedural Delays

    Olympus SPiN Drive needles have an electromagnetic sensor tracking malfunction that impairs navigation during endobronchial clinical procedures. Affected devices may generate false coil break warnings and cause procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Mode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2023·2023-08-09

    Bronchoscopy Instruments Recalled for Electromagnetic Sensor Tracking Malfunction

    Olympus Corporation is recalling Always-On Tip Tracked Instruments due to a malfunction in the electromagnetic sensor that impairs navigation functionality during bronchoscopic procedures. The malfunction could result in procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2023·2023-08-09

    Endobronchial Cytology Needles Recalled for Electromagnetic Sensor Malfunction

    Olympus is recalling endobronchial navigation needles because an electromagnetic sensor malfunction can disable navigation guidance during medical procedures, potentially causing procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2023·2023-08-09

    Olympus Forceps Model INS-0362 Navigation Sensor Malfunction During Procedures

    Always-On Tip Tracked Instruments forceps (Model INS-0362) may experience electromagnetic sensor tracking malfunction during endobronchial procedures, impairing navigation functionality and causing procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0362
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2023·2023-08-09

    Olympus SPiN Drive Histology Needle Recalled for Navigation Sensor Malfunction

    Olympus recalls SPiN Drive histology needles due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2023·2023-06-28

    Masimo Ear Oxygen Sensor Readings May Fall Outside Accuracy Specifications

    Masimo is recalling 123,745 reusable ear sensors that may produce inaccurate oxygen saturation readings. The affected devices were distributed throughout the US and 48 additional countries.

    Product
    Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
    Category
    Medical Device
    Distribution
    51 states
  • ModerateCPSC·23226·2023-06-22

    Poseidon M28A Dive Computers Recalled Due to Water Intake Hazard

    Poseidon M28A Dive Computers can stop working when water enters the device, causing the depth sensor to malfunction and loss of dive data. The firm has received one report of water intake but no injuries have been reported.

    Product
    Poseidon M28A Dive Computers
    Category
    Consumer Product
    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-1288-2023·2023-04-12

    Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen

    The Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen during high-concentration therapy due to accuracy deviations. The device's internal oxygen sensor may also display incorrect readings, creating a risk of oxygen under-delivery to patients.

    Product
    Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1289-2023·2023-04-12

    Philips Trilogy Evo Portable Ventilators Recalled for Inaccurate Oxygen Delivery

    Philips Respironics is recalling the Trilogy Evo Universal Portable Electric Ventilator (Model DS2000X11B) because it may deliver oxygen below the prescribed level during high-concentration oxygen therapy, potentially depriving patients of adequate oxygen.

    Product
    Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide