The Recall Desk

Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,800
Critical
31
Severe
370
Most recent
2026-09-02

Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (21%) 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 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.

1–25 of 1800

  • HighFDA (Devices)·Z-2988-2026·2026-09-02

    Philips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan

    Philips is recalling Incisive CT scanners with specific software versions due to a potential failure to trigger clinical scans during bolus tracking.

    Product
    Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2962-2026·2026-08-26

    Boston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices

    Boston Scientific is recalling Suture Cinch Long endoscopic tissue approximation devices because they may fail to deploy the implant or cut the suture.

    Product
    Suture Cinch Long 1pk. Endoscopic tissue approximation device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2872-2026·2026-08-26

    BD Needle Kit for Powered Driver Recall Due to Removal Difficulty

    Bard Access Systems is recalling BD Needle Kits for Powered Drivers because the obturator may lock to the hub, potentially delaying emergency therapy.

    Product
    BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Dr
    Category
    Medical Device
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2862-2026·2026-08-12

    Stryker AHTO Tube Set Packaging Recalled for Handpiece Leaking

    Stryker is recalling 46,212 units of its AHTO Tube Set Packaging (Catalog Number 0250070600) due to reported complaints of leaking from the handpiece during use. The recall affects products distributed worldwide, including US Nationwide and multiple countries.

    Product
    STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2900-2026·2026-08-12

    GEM Premier 5000 PAK Lysing Solution Concentration Recall

    Specific lots of the GEM Premier 5000 PAK lysing bag solution have an active ingredient concentration that does not meet manufacturing specifications, which could delay recognition and management of Co-Oximetry and total bilirubin abnormalities.

    Product
    GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2837-2026·2026-08-12

    Integrated Medcraft Recalls First Aid Kits with Defective Airway Tips

    Integrated Medcraft is recalling specific Kingfisher Compact Individual First Aid Kits because the included Guedel airway components may have occluded tips.

    Product
    Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2911-2026·2026-08-12

    Neuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk

    Contego Medical, Inc is recalling Neuroguard IEP Carotid Stent and Post-Dilation Balloon Systems due to a potential filter failure issue.

    Product
    Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2650-2026·2026-08-05

    Philips CT Scanners Recalled Due to Bolus Tracking Trigger Issue

    Philips is recalling certain CT scanners because the clinical scan may not start automatically after Bolus Tracking, which could require a patient rescan and expose them to additional radiation.

    Product
    Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2651-2026·2026-08-05

    Philips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure

    Philips is recalling IQon Spectral CT systems because the clinical scan may not start automatically after Bolus Tracking, requiring manual triggering and potentially causing extra radiation exposure.

    Product
    IQon Spectral CT IQon Spectral CT Upgrades
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2652-2026·2026-08-05

    Philips Ingenuity CT Scanners Recalled Due to Bolus Tracking Trigger Issue

    Philips is recalling 182 Ingenuity CT systems in the US because the clinical scan may not trigger automatically after Bolus Tracking, potentially causing patient rescan and extra radiation.

    Product
    Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2756-2026·2026-07-29

    Boston Scientific Steerable Sheath Recalled Due to Potential Air Embolism Risk

    Boston Scientific is recalling FARADRIVE STEERABLE SHEATH (CLEAR) because improper dilator insertion can damage the hemostatic valve, potentially leading to air ingress and air embolism.

    Product
    FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2753-2026·2026-07-29

    Boston Scientific Recalls FARASTAR Ablation Generators Due to Catheter Incompatibility

    Boston Scientific is replacing specific FARASTAR PFA generators that are not compatible with the FARAPOINT PFA catheter. The FDA Class II recall affects 6 units distributed internationally.

    Product
    FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2775-2026·2026-07-29

    SnapshotGLO Wound Imaging Device Recalled Due to Battery Charging Software Issue

    Kent Imaging, Inc. is recalling SnapshotGLO Wound Imaging Devices (Models KB100 and KB100AA) because software issues may prevent the device from recharging.

    Product
    SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2689-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk

    ABIOMED is recalling Impella CP heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The manufacturing defect is not visually detectable.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2026·2026-07-08

    IntelliCuff Portable Automatic Cuff Pressure Controller Recall

    Hamilton Medical AG is recalling the IntelliCuff portable automatic cuff pressure controller due to a reported "Cuff System Leakage" error that may cause the motor to pump continuously and fail to maintain user-set cuff pressure.

    Product
    IntelliCuff, Portable automatic cuff pressure controller REF: 951001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2609-2026·2026-07-08

    Medline Convenience Kits Containing Recalled Swan-Ganz Catheters

    Medline is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2643-2026·2026-07-08

    ARTIS icono floor Medical Imaging System Detector Movement Loss Recall

    Siemens Medical Solutions is recalling 30 units of the ARTIS icono floor (Model 11327700) due to potential loss of detector movement capability when adjusted to maximum or minimum height limits.

    Product
    ARTIS icono floor. Model Number: 11327700.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2473-2026·2026-06-24

    ConMed AirSeal 12mm bladeless optical obturators may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Low Profile Bladeless Optical Tip Obturators are being recalled because of the potential for overpressure alerts. 71,151 packs affected.

    Product
    ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2474-2026·2026-06-24

    ConMed AirSeal 12mm palm grip 100mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2469-2026·2026-06-24

    ConMed AirSeal 5mm 75mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 75 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2026·2026-06-24

    ConMed AirSeal 5mm 100mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2472-2026·2026-06-24

    ConMed AirSeal 12mm palm grip 150mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 150 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2026·2026-06-24

    ConMed AirSeal 12mm blunt tip 100mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip, 100 mm length, are being recalled because of the potential for overpressure alerts. 1,261 packs affected.

    Product
    ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2026·2026-06-24

    ConMed AirSeal 8mm 100mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 8 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide