The Recall Desk

Hazard

Device Malfunction recalls

1,813 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,813
Critical
31
Severe
463
Most recent
2026-10-21

Of the 1,813 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 463 (26%) 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 1813

  • SevereFDA (Devices)·Z-0136-2027·2026-10-21

    JenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation

    Jenavalve Technology Inc. is recalling 143 JenaValve Trilogy Delivery Catheters due to a defect that may prevent heart valve deployment.

    Product
    JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0134-2027·2026-10-21

    JenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation

    Jenavalve Technology Inc. is recalling 111 units of JenaValve Trilogy Delivery Catheters due to a defect that may prevent heart valve deployment.

    Product
    JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0135-2027·2026-10-21

    JenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation

    Jenavalve Technology Inc. is recalling 108 units of the JenaValve Trilogy Delivery Catheter due to a defect that may prevent heart valve deployment.

    Product
    JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0183-2027·2026-10-21

    Medline recalls CONMED AirSeal Access Port kits due to overpressure alerts

    Medline is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports because they may trigger erroneous overpressure alerts and system venting, potentially delaying or ending surgical procedures.

    Product
    Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B DYNJG901002C DYNJG901002D GENERAL DAVINCI DYNJG901004B DYNJG901004D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2027·2026-10-21

    Medline Recalls Convenience Kits Containing CONMED AirSeal Access Ports

    Medline Industries is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports due to potential overpressure alerts and system venting that may delay or end procedures.

    Product
    Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2027·2026-10-21

    Medline recalls CONMED AirSeal Access Port kits due to pressure alert issues

    Medline Industries is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports due to potential erroneous overpressure alerts and system venting.

    Product
    Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0088-2027·2026-10-14

    Medtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests

    Medtronic is recalling 20 MiniMed Flex insulin pumps that failed or lacked verification test results, posing risks of inaccurate insulin delivery and device malfunctions.

    Product
    Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3192-2026·2026-09-23

    Datex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption

    Datex-Ohmeda is recalling 410 Et Control software units for anesthesia gas machines that may interrupt anesthetic delivery, requiring clinician intervention to prevent decreased patient effect.

    Product
    Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3189-2026·2026-09-23

    Datex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect

    Datex-Ohmeda is recalling Aisys anesthesia systems because electronic gas mixer assemblies may fail, interrupting anesthetic delivery and requiring clinician intervention.

    Product
    Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3190-2026·2026-09-23

    Datex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect

    Datex-Ohmeda is recalling 140 Aisys CS2 anesthesia systems because electronic gas mixer assemblies may fail, interrupting anesthetic delivery and requiring clinician intervention.

    Product
    Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3191-2026·2026-09-23

    Datex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect

    Datex-Ohmeda is recalling seven Aisys CS2 anesthesia systems because a gas mixer defect can interrupt anesthetic delivery, requiring clinician intervention to prevent decreased patient effect.

    Product
    Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3177-2026·2026-09-23

    Wilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues

    Wilson-Cook Medical Inc. is recalling 121,241 units of Hemospray Endoscopic Hemostat due to issues with endoscope adherence and the inability to spray powder.

    Product
    Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscopic gastrointestinal use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3120-2026·2026-09-16

    HeartSine SAM Public Access Defibrillators Recalled for Damaged Membrane Tail

    HeartSine Technologies is recalling SAM 350P, 360P, and 450P defibrillators due to a damaged membrane tail that causes intermittent faults.

    Product
    HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    32 states
  • 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
  • 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-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
  • 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
  • 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