The Recall Desk

Hazard

Thermal Injury recalls

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

What the numbers show

Total
42
Critical
0
Severe
8
Most recent
2026-06-10

Of the 42 thermal injury recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (19%) 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 thermal injury 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 42

  • HighFDA (Devices)·Z-2279-2026·2026-06-10

    CASE cardiac testing systems may spark at the printer head

    CASE v7.0 Cardiac Testing Systems are being recalled because electrical sparking may occur at the printer head, and ignition of thermal paper could cause serious thermal injury.

    Product
    CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2025·2025-08-27

    Endoscopy video processors recalled over hot light guide and thermal injury risk

    Pentax Medical EPK-i8020c video processors are recalled after reports of darkened images, smoke-like steam and a hot endoscope light guide that may cause thermal injury to the patient's mucous membrane. 144 units are affected.

    Product
    Pentax Medical Video Processor; Model Number: EPK-i8020c;
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1236-2025·2025-03-05

    Video Colonoscope May Cause Thermal Burns to Tissue During Use

    The PENTAX Medical Video Colonoscope (Model EC38-i20cL) can develop excessive heat at the tip during procedures, potentially causing thermal burns to patient tissue. Users reported dark images and steam-like smoke from the device.

    Product
    PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2728-2024·2024-09-04

    Stryker iBur Surgical Bur Recall Due to Excessive Heat Risk

    Stryker is recalling iBur 4.0mm Coarse Diamond surgical burs that may overheat during use. Excessive heat could cause tissue or bone damage requiring medical intervention.

    Product
    Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2725-2024·2024-09-04

    Stryker surgical bur may overheat and cause thermal tissue damage

    Stryker iBur surgical burs may overheat during use in neurosurgery and spine surgery, potentially causing thermal tissue damage requiring medical intervention. Approximately 2,507 units were distributed worldwide.

    Product
    Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2729-2024·2024-09-04

    Stryker iBur surgical bur recalled for potential overheating at junction

    Stryker has recalled 1171 units of iBur 5.0mm surgical burs due to potential overheating at the bur shank junction. The overheating could cause thermal injury requiring medical intervention.

    Product
    Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2723-2024·2024-09-04

    Stryker iBur 4.0mm surgical bur recall: excessive heat risk during bone surgery

    Stryker iBur 4.0mm precision surgical burs may overheat where the shank meets the distal bushing. Excessive heat could cause minor tissue damage or thermal injury requiring medical intervention.

    Product
    Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2724-2024·2024-09-04

    Stryker iBur 2.0mm Diamond Round Burr Thermal Hazard Recall

    Stryker recalled 1,226 iBur surgical burrs with multiple lot numbers worldwide due to potential overheating at the bur-shank connection point, which could cause tissue damage requiring medical intervention.

    Product
    Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2024·2024-09-04

    Stryker iBur surgical burs recalled due to overheating risk

    Stryker Corporation recalls iBur 3.0mm surgical burs used in neurosurgery, spinal, and ENT procedures due to potential overheating at the bur-shank interface. The heat risk may cause tissue damage requiring medical intervention.

    Product
    Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2722-2024·2024-09-04

    Stryker iBur Surgical Bur Recalled Due to Excessive Temperature Risk

    Stryker recalls iBur 3.0mm Precision Round surgical burs due to potential for excessive temperatures where the bur shank meets the bushing. Thermal injury risk may require medical intervention.

    Product
    Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2731-2024·2024-09-04

    Stryker iBur 3.0mm surgical burr recalled over thermal hazard

    Stryker Corporation is recalling the iBur 3.0mm Precision Match Head surgical burr because it may generate higher-than-specified temperatures during use, potentially causing thermal injury that may require medical intervention.

    Product
    Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2024·2024-08-14

    GE MR450w 1.5T MRI software defect may cause implant overheating

    GE MR450w 1.5T MRI systems may overheat MR-conditional implants when using specific imaging sequences with Low SAR Mode. No injuries reported; 1,607 units affected worldwide.

    Product
    Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2475-2024·2024-08-14

    GE SIGNA MR355 MRI System Recalled for Potential Implant Overheating Risk

    GE SIGNA MR355 MRI systems running software versions SV25.5 or SV25.6 may cause implant overheating in certain scanning conditions. Risk occurs when using specific imaging sequences with the Optimized T2 FLAIR feature disabled.

    Product
    SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2470-2024·2024-08-14

    GE SIGNA Voyager MRI systems risk implant overheating under specific configurations

    GE SIGNA Voyager MRI systems may exceed prescribed radiofrequency limits under specific operating conditions, risking overheating of MR conditional implants. The issue occurs with certain imaging sequences when the Optimized T2 FLAIR option is disabled.

    Product
    SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2478-2024·2024-08-14

    GE Optima MR360 MRI System Software May Overheat Implants

    GE Optima MR360 MRI systems with affected software versions may exceed safe radiofrequency energy limits, potentially overheating MR-conditional implants when specific imaging sequences are used. 469 units are affected worldwide.

    Product
    Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2314-2024·2024-07-17

    Baxter Trulight Surgical Lights Recalled for Thermal Skin Injuries

    Baxter Healthcare Corporation recalled Trulight 5000/3000 Surgical Light systems due to customer reports of thermal skin injuries. The urgent medical device correction affects models 4038210 and 4038310 distributed worldwide.

    Product
    Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1830-2024·2024-05-22

    Philips Ingenia 3.0T MR Systems May Not Warn of Low Ventilation Settings

    Philips Ingenia 3.0T MR systems with software R5.7.1 may fail to warn about low ventilation, potentially causing patient overheating or burning sensations. 19 units affected worldwide.

    Product
    Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2024·2024-05-22

    MRI System Software May Fail to Warn of Inadequate Ventilation

    Philips Ingenia 1.5T MRI systems with software R5.7.1 may not provide adequate warning for low ventilation conditions, potentially causing increased patient body temperature or burning sensation.

    Product
    Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0193-2024·2023-11-15

    Olympus Bronchovideoscope Recalled Due to Combustion Risk

    Olympus is recalling 719 EVIS EXERA b Bronchovideoscope Model BF-XT190 devices due to risk of endobronchial combustion during high-frequency cauterization when oxygen is supplied or the electrode is too close to the device tip.

    Product
    EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2023·2023-04-26

    Habib EndoHPB Bipolar RF Catheter Recalled Due to Thermal Injury Risk

    Boston Scientific recalls the Habib EndoHPB Bipolar RF Catheter used in pancreatic and biliary procedures due to inaccurate instructions that could result in excessive energy delivery and thermal injury.

    Product
    Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. UPN: M00500070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0190-2023·2022-11-16

    Cardinal Health Insulated Gel Pack Reusable Medium Contraindicated for Infant Use

    Cardinal Health recalls approximately 649,213 insulated gel packs due to contraindication for infants and neonates. Labeling will be revised with a caution statement.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Restricted for Infants

    Cardinal Health is restricting use of 567,475 reusable hot and cold gel packs (Model M) on infants and neonates due to thermal injury risk. Updated labeling will warn against use on this vulnerable population.

    Product
    Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2022·2022-05-04

    Acuson 9vE4 Ultrasound Transducers Recalled for Potential Thermal Injury Risk

    Siemens is recalling 31 Acuson 9vE4 ultrasound transducers that may exceed thermal index limits, creating a potential risk of thermal injury. Affected units were distributed in US states and international locations.

    Product
    Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0210-2022·2021-11-17

    Covidien Emprint Ablation Catheter temperature monitoring defect

    Covidien is recalling the Emprint Ablation Catheter due to a defect in temperature monitoring circuitry. If the cooling system fails during use, the device tip could overheat, causing tissue burns, unintended ablation, and allergic reactions.

    Product
    Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0283-2021·2020-11-04

    Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Error

    Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller because improper calibration may cause the endoscope tip to reach higher temperatures, potentially leading to thermal tissue injury.

    Product
    da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform mi
    Category
    Medical Device
    Distribution
    Distributed nationwide