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.

501–525 of 1800

  • HighFDA (Devices)·Z-2403-2023·2023-09-13

    Azurion imaging systems recalled for stuck foot switch causing unintended radiation

    Philips recalls Azurion imaging systems because the foot switch pedal may stick in the active position, causing unintended radiation emission. Facilities should stop using the systems and contact Philips for guidance.

    Product
    Azurion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2438-2023·2023-09-06

    Cardiosave Rescue Intra-Aortic Balloon Pumps Recalled Due to Autofill Failure

    Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failures that can cause the pump to stop.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2023·2023-09-06

    Philips Wireless Foot Switch for X-Ray Systems Risks Loss of Function During Procedures

    Philips is recalling wireless foot switches used with Allura Xper and Azurion X-ray systems because they may become unavailable during procedures. Approximately 1,865 units were distributed worldwide.

    Product
    Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2023·2023-09-06

    Olympus Bronchovideoscope Recalled for Risk of Lodging in Airway Connector

    Olympus Corporation is recalling 1,004 units of the Bronchovideoscope Model BF-3C160 due to a dimensional defect that can cause the endoscope to become lodged in an endotracheal tube connector.

    Product
    Olympus Bronchovideoscope, Models BF-3C160.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2411-2023·2023-08-23

    Alcon Custom Pak Intraocular Lens Packages Recalled for Plastic Debris Risk

    Alcon Custom Pak intraocular lens packages are recalled due to reports of patient injury during surgical procedures caused by plastic debris from over-tightening with the included plastic wrench.

    Product
    Alcon Custom Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2425-2023·2023-08-23

    Endoscopic Surgical Dissectors Recalled for Potential Rotation Knob Cracking

    Carefusion 2200 Inc recalls 42 units of Snowden-Pencer surgical dissectors distributed in the US and Canada due to potential cracking of the rotation knob caused by an adhesive defect in manufacturing.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2414-2023·2023-08-23

    FreeStyle Libre 2 Readers may fail to activate new sensors

    FreeStyle Libre 2 Readers may display an 'Incompatible Sensor' error when attempting to activate a new sensor after incomplete 14-day wear, potentially preventing new sensor activation and causing delayed glucose monitoring.

    Product
    FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2426-2023·2023-08-23

    Endoscopic surgical graspers recalled for potential rotation knob failure

    Carefusion is recalling specific lots of Snowden-Pencer surgical graspers used in endoscopy due to a manufacturing defect that could cause the rotation knob to crack or break. The affected instrument may malfunction during surgical procedures.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2361-2023·2023-08-16

    Siemens ARTIS Angiography Systems: Thermal Overload Risk in Cable Connectors

    Siemens has recalled 10 ARTIS angiography systems due to thermal overload hazard in cable connectors. The issue may cause burning smell and loss of imaging functionality, potentially requiring treatment cancellation or system replacement.

    Product
    ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2023·2023-08-09

    MEGADYNE Suction Coagulators recalled for fluid ingress causing device malfunction

    Megadyne Medical Products is recalling 241,457 MEGADYNE Suction Coagulators due to fluid ingress into the handpiece, which may cause unintended activation, failure to activate, or self-activation during surgical procedures.

    Product
    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2023·2023-08-09

    Philips CT scanner heat exchanger box may detach and cause injury

    The metal mounting box on the rotating scanner of the Incisive CT system may become detached and contact other components, potentially injuring users or causing system shutdown.

    Product
    Incisive CT-Computed Tomography X-Ray System Model: 728143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2023·2023-08-09

    Fusion Lithotripsy Extraction Baskets recalled for mechanical defects

    Wilson-Cook Medical's Fusion Lithotripsy Extraction Baskets are being recalled due to mechanical defects that can prevent the basket from advancing or retracting, or cause the drive wire to break or separate during use.

    Product
    Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2140-2023·2023-08-02

    HAMILTON T1 Ventilator software defect may cause unexpected shutdown

    Hamilton Medical is recalling 2,319 HAMILTON T1 Ventilators due to a software anomaly that may cause the device to stop and enter ambient mode after approximately 91 days of use.

    Product
    HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-2241-2023·2023-08-02

    Hernia repair implant balloon may not inflate as intended

    Davol's Ventralight ST hernia repair implant balloon may fail to inflate properly during laparoscopic surgery. This could result in procedure delay, inadequate mesh placement, and risk of infection.

    Product
    Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2243-2023·2023-08-02

    Ventral Hernia Mesh Balloon May Fail to Inflate During Surgery

    A surgical mesh implant used in ventral hernia repair may fail to inflate properly during the procedure, potentially causing inadequate placement and infection risk. The manufacturer is recalling 169 units worldwide.

    Product
    Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2023·2023-08-02

    Argon Medical Option Elite Vena Cava Filter Recall Due to Performance Risk

    Argon Medical Devices is recalling 3 Option Elite Retrievable Vena Cava Filters due to a potential performance defect that could result in pulmonary embolism. Affected units were distributed in Texas.

    Product
    Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2023·2023-08-02

    FRED Flow Re-Direction Endoluminal Device recalled for incorrect inner stent length

    The FDA is recalling FRED Flow Re-Direction Endoluminal Devices due to a manufacturing defect that may result in incorrect inner stent length, potentially affecting device performance. 474 units were affected.

    Product
    FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2023·2023-08-02

    Laser Fiber Devices May Overheat and Cause Burns During Use

    Boston Scientific is recalling Flexiva Pulse 242 laser fibers due to manufacturing defects that may cause the fiber connector to overheat and cause burn injuries. The recall affects 1,245 units distributed in the US and Canada.

    Product
    Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2023·2023-08-02

    Laser fiber medical devices recalled for potential burn injury hazard

    Boston Scientific recalls Flexiva Pulse laser fibers due to manufacturing defects that can cause fiber connector overheating and potential burns if touched. Affects 280 units in US and Canada.

    Product
    Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1941-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Recall Due to Device Malfunction

    Teleflex is recalling 20,042 endotracheal tubes due to reports of 15mm connector disconnection that could compromise airway management. The FDA classified this as a Class I recall.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1856-2023·2023-07-05

    Flexi-Set Endotracheal Tube Recalled for Connector Disconnection

    Teleflex is recalling 18,353 Flexi-Set Uncuffed Endotracheal Tube sets nationwide due to reports of 15mm connector disconnection. The defect could affect ventilation during use.

    Product
    Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1860-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Recall

    TELEFLEX LLC is recalling Slick Set Cuffed Endotracheal Tubes (REF 1700100) due to reports of the 15mm connector disconnecting from the device during use.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1958-2023·2023-07-05

    Teleflex Endotracheal Tubes Recalled Due to Connector Disconnection Risk

    Teleflex endotracheal tubes are recalled nationwide due to reported disconnection of the 15mm connector. The recall affects 1,750 units distributed across the US and Puerto Rico.

    Product
    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1886-2023·2023-07-05

    Teleflex Endotracheal Tubes Recalled for Connector Disconnection Risk

    Teleflex is recalling approximately 170,610 endotracheal tubes due to reports of 15mm connector disconnection. The disconnection could compromise airway management during mechanical ventilation.

    Product
    Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1929-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Risk - Teleflex Magill Recall

    TELEFLEX LLC is recalling 3,031 Endotracheal Tube units due to reports of 15mm connector disconnection. The affected Magill model (REF 100380045) was distributed nationwide.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045
    Category
    Medical Device
    Distribution
    Distributed nationwide