The Recall Desk

Hazard

Device Malfunction recalls

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

About this hazard tag

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

126–150 of 877

  • HighFDA (Devices)·Z-0212-2026·2025-10-29

    BIOMET ZipTight AC Joint Implant Recalled for Potential Missing Button Assembly

    Biomet is recalling one lot of ZipTight AC Joint Implants due to a potential missing slotted button assembly that could compromise fixation. The recalled lot contains 98 units.

    Product
    BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0288-2026·2025-10-29

    HeartSine Defibrillator Pads Recalled for Defective Electrical Contacts

    HeartSine Pad-Pak defibrillator pads may contain damaged pins that disrupt electrical contact and mechanical fit. Over 1.2 million units are affected in the U.S. and worldwide.

    Product
    HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2026·2025-10-29

    Salem Sump Stomach Tubes Recalled for Anti-Reflux Valve Breakage Risk

    Cardinal Health is recalling Salem Sump stomach tubes because the anti-reflux valve can break when excessive force is applied during use. The firm is providing additional guidance to help users prevent valve damage.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Du
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0258-2026·2025-10-29

    SEDECAL Mobile X-ray System Susceptible to Water Damage if Improperly Cleaned

    SEDECAL recalls 39 mobile X-ray systems that are not water-resistant. Improper cleaning can result in damage; users must follow manual instructions strictly.

    Product
    Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0248-2026·2025-10-29

    Mobile X-ray System Requires Proper Cleaning to Prevent Water Damage

    SEDECAL is reminding users that its Model 40KWFXPLUS.004 mobile X-ray system is not water-resistant and must be cleaned per manual instructions to prevent equipment damage.

    Product
    Model Number 40KWFXPLUS.004, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0094-2026·2025-10-22

    Boston Scientific Pacemaker Software Update to Prevent Safety Mode

    Boston Scientific is issuing a software update for ACCOLADE family pacemakers to prevent improper Safety Mode activation related to high battery impedance in ambulatory settings. The update affects approximately 61,700 units of multiple pacemaker models distributed worldwide.

    Product
    Model Number L110, ESSENTIO SR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0103-2026·2025-10-22

    Pacemaker Recall: Boston Scientific VISIONIST CRT-P for Safety Mode Malfunction

    Boston Scientific's VISIONIST CRT-P pacemakers recalled due to unintended Safety Mode activation from high battery impedance. Software update is available to prevent the malfunction.

    Product
    Model Number U225 VISIONIST CRT-P EL
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0104-2026·2025-10-22

    Boston Scientific Pacemakers Recalled for Battery Impedance Software Issue

    Boston Scientific is recalling 1,050 pacemaker and cardiac resynchronization therapy devices worldwide due to potential high battery impedance causing unwanted Safety Mode activation. Software to prevent this issue is available.

    Product
    Model Number U226, VISIONIST CRT-P EL
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0090-2026·2025-10-22

    Pacemakers Software Update Required to Prevent Unintended Safety Mode

    Boston Scientific issued a Class I recall for multiple pacemaker models due to potential unintended Safety Mode initiation during high battery impedance conditions. Software is available to prevent this.

    Product
    Model Number L221 PROPONENT DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0093-2026·2025-10-22

    ESSENTIO DR SL Pacemaker Safety Mode Software Recall

    Boston Scientific is recalling ESSENTIO DR SL and related pacemakers that may inappropriately enter Safety Mode due to high battery impedance. A software update has been released to prevent this condition.

    Product
    Model Number L101, ESSENTIO DR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0084-2026·2025-10-22

    Pacemaker Software Update to Prevent Unintended Safety Mode Activation

    Boston Scientific is recalling certain pacemakers due to potential unintended Safety Mode activation. A software update is available to address the issue in over 34,000 affected devices.

    Product
    ACCOLADE DR EL MRI (Model L331)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0097-2026·2025-10-22

    Boston Scientific Pacemakers Software Update Required for Safety Mode Issue

    Boston Scientific pacemakers may experience inappropriate Safety Mode activation in ambulatory settings due to high battery impedance. Software to address this issue is available; contact your healthcare provider.

    Product
    Model Number L131, ESSENTIO DR EL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0111-2026·2025-10-22

    Abbott TactiFlex Ablation Catheter Recalled for Tip Detachment During Removal

    Abbott is recalling approximately 85,803 TactiFlex Sensor Enabled Ablation Catheters due to tip detachment occurring during removal from packaging in a limited number of units.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0089-2026·2025-10-22

    Multiple Boston Scientific Pacemaker Models Recalled for Safety Software Issue

    Boston Scientific pacemakers may inappropriately activate Safety Mode in ambulatory settings due to high battery impedance. A software update is available to address this issue.

    Product
    Model Number L211 PROPONENT DR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0081-2026·2025-10-22

    Pacemakers Recalled for Possible Unwanted Safety Mode Activation

    Boston Scientific pacemakers may incorrectly enter safety mode in ambulatory settings when battery impedance is high. A software update is available to fix this issue.

    Product
    ACCOLADE SR SL MRI (Model L310)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0092-2026·2025-10-22

    Pacemaker Software Update to Prevent Inappropriate Safety Mode Activation

    Boston Scientific is issuing a software update for ESSENTIO and related pacemaker models to prevent inappropriate Safety Mode activation in ambulatory settings when battery impedance is high.

    Product
    Model Number L100, ESSENTIO SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0100-2026·2025-10-22

    Boston Scientific Pacemakers Software Issue Can Trigger Inappropriate Safety Mode

    Boston Scientific is recalling certain ACCOLADE family pacemakers, including ALTRUA 2 models, because a software issue can cause inappropriate Safety Mode activation in ambulatory settings. A software update is available to prevent this malfunction.

    Product
    Model Number S722, ALTRUA 2 DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0098-2026·2025-10-22

    Pacemaker Software Defect Recall: Unintended Safety Mode Activation Risk

    Boston Scientific recalls certain pacemaker models that may unintentionally activate Safety Mode in ambulatory settings due to high battery impedance. Software is available to correct this defect.

    Product
    Model Number S701 ALTRUA 2 SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0083-2026·2025-10-22

    Pacemakers Recalled for Software Update to Prevent Safety Mode Activation

    Boston Scientific is recalling pacemakers and cardiac resynchronization therapy devices due to a battery impedance issue that could trigger unwanted Safety Mode in ambulatory settings. A software update is available to prevent this condition.

    Product
    ACCOLADE DR EL (Model L321)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0080-2026·2025-10-22

    Class I Pacemaker Recall: ACCOLADE Family Safety Mode Software Issue

    Boston Scientific recalls ACCOLADE family pacemakers due to a software issue that could cause Safety Mode to activate unintentionally when battery impedance is high. Software update is available to prevent this activation.

    Product
    ACCOLADE DR SL (Model L301)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0144-2026·2025-10-22

    LGX Preconnect TENACIO Pump Devices Recalled for Inflation and Deflation Issues

    Boston Scientific is recalling LGX Preconnect with TENACIO Pump devices that may experience inflation or deflation performance problems. Approximately 490 units were distributed to the US and Canada.

    Product
    LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2026·2025-10-22

    FDA Recalls Baxter IV Extension Sets Due to Potential Leakage

    Baxter Healthcare recalls 16,416 CLEARLINK System Extension Sets due to potential leakage. The nationwide recall affects IV extension sets that may not function properly during use.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
    Category
    Medical Device
    Distribution
    Distributed nationwide