The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
881
Critical
30
Severe
255
Most recent
2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) 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 device failure 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.

151–175 of 881

  • HighFDA (Devices)·Z-2415-2023·2023-08-23

    Snowden-Pencer Surgical Grasper Recalled for Cracking Rotation Knob

    Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS Diamond-Touch Grasper surgical tool due to defects in the rotation knob adhesive that may cause cracking or breaking during use.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2427-2023·2023-08-23

    Endoscopic surgical clamp recalled for potential rotation knob failure

    Carefusion recalls Snowden-Pencer MIS Diamond-Touch Clamps (Lot B23) due to potential cracking of the rotation knob from incorrect adhesive use. The 7 affected units were distributed to the US and Canada.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2424-2023·2023-08-23

    Endoscopic surgical grasper recalled due to rotation knob defect

    Carefusion is recalling specific lots of Snowden-Pencer Diamond-Touch endoscopic graspers due to a manufacturing defect that may cause the rotation knob to crack or break. Affected units were distributed in the US and Canada.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2281-2023·2023-08-09

    Impella RP Flex cardiac pump recalled for thrombus formation risk

    The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.

    Product
    Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2223-2023·2023-08-02

    LINEAR intra-aortic balloon catheter introducer dilator fracture risk

    Datascope's LINEAR intra-aortic balloon catheters may develop a fractured introducer dilator that can injure blood vessels or cause dangerous blockages. The company has received 10 complaints including 1 death and 3 serious adverse events.

    Product
    LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2141-2023·2023-08-02

    Hamilton C2 Ventilator recalled for software anomaly causing loss of function

    FDA is recalling 399 Hamilton C2 Ventilators due to a software anomaly that may cause the device to stop unexpectedly after approximately 91 days of use. Affected facilities should verify serial numbers and contact the manufacturer.

    Product
    HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2018-2023·2023-07-19

    Oxylog 3000 Plus ventilator may stop working during operation

    The Draeger Oxylog 3000 Plus emergency and transport ventilator may stop working when transitioning from battery to AC operation. Approximately 300 units distributed nationwide and internationally are affected.

    Product
    Oxylog 3000 Plus emergency and transport ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2023·2023-07-19

    Surgical chest support device recalled for potential cracking at attachment

    Baxter Healthcare recalls 1,010 Allen Advance Chest Support devices due to potential cracking where the support attaches to operating room table rails. No injuries reported.

    Product
    Allen Advance Chest Support with Pad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1829-2023·2023-07-05

    Slick Set Endotracheal Tubes recalled for connector disconnection risk

    Teleflex is recalling Slick Set Cuffed Endotracheal Tubes nationwide due to reported disconnection of the 15mm connector from the tube, affecting airway management in critical care settings.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2023·2023-07-05

    LINK Endo-Model Knee Prosthesis Segments Recalled for Out-of-Specification Defects

    The FDA has recalled 13 LINK Endo-Model knee prosthesis femoral segments because they may not meet manufacturing specifications. The defects were discovered through customer complaints.

    Product
    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2008-2023·2023-07-05

    ILLUMISITE Platform Console Incorrectly Converted with Non-Supplied Power Components

    A Medtronic ILLUMISITE Platform Console was modified from 220-240VAC to 120VAC using non-supplied power cord and fuses, creating electrical hazards. One unit was distributed to Taiwan.

    Product
    Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1752-2023·2023-06-28

    Medtronic CRT-D BRAVA Implantable Defibrillators—Potential High-Voltage Therapy Failure

    Medtronic implantable cardioverter defibrillators with specific feedthrough components may fail to deliver high-voltage therapy during treatment. Affected units are being recalled due to risk of reduced or absent energy output.

    Product
    CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1778-2023·2023-06-28

    Implantable Defibrillators May Deliver Reduced Energy During Therapy

    Medtronic ICDs and CRT-Ds with a specific feedthrough may deliver reduced or no energy during high voltage therapy. Approximately 2,669 units are affected in the US and worldwide.

    Product
    CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1818-2023·2023-06-28

    Medtronic ICD COBALT XT Recalled for Potential Energy Output Failure

    Medtronic has recalled certain implantable defibrillators (ICDs) due to a potential for reduced or no-energy output during therapy. Affected devices may fail to deliver required treatment for dangerous heart rhythms.

    Product
    ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1715-2023·2023-06-28

    Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic is recalling approximately 10,900 ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a feedthrough component defect. No illnesses reported, but the rare defect poses risk of inadequate device function during critical treatment.

    Product
    ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2023·2023-06-21

    Aspira Peritoneal Drainage Catheter Insertion Tray valve malfunction

    Merit Medical's Aspira Peritoneal Drainage Catheter Insertion Tray valve assemblies may fail to open, preventing fluid drainage. 175 units distributed nationwide and internationally are affected.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2023·2023-06-07

    Smith & Nephew ENGAGE Knee System Recalled for Elevated Revision Risk

    Smith & Nephew's ENGAGE Cementless Partial Knee System is being recalled due to higher-than-expected revision rates compared to similar devices. The recall affects 7,531 units distributed nationwide.

    Product
    Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2023·2023-05-10

    Knee implant system recalled due to risk of aseptic loosening

    The LINK SLED Knee System has been recalled due to risk of early aseptic loosening and wear caused by suboptimal implant positioning or inadequate cementing technique during surgery.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1423-2023·2023-05-03

    Biopsy forceps may fail to open when endoscope is bent

    Biopsy forceps may become unable to open when the endoscope shaft is bent approximately 90 degrees. Additional bending of the forceps shaft can prevent opening entirely.

    Product
    FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2023·2023-04-26

    Medacta MectaLIF ANTERIOR spine implant recalled due to screw breakage risk

    Medacta USA is recalling MectaLIF ANTERIOR interbody fusion devices due to a potential for breakage of a small screw that secures the anti-backout plate. The defect affects 44 units distributed across five US states.

    Product
    MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1359-2023·2023-04-19

    Titan Touch Pump Inflatable Prosthesis Recalled for Structural Defect Risk

    Coloplast Manufacturing is recalling Titan Touch Pump inflatable penile prostheses due to manufacturing defect causing decreased wall thickness that could lead to premature device failure.

    Product
    Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2023·2023-03-29

    BD Pyxis Automated Medication Dispensing Systems Firmware Downgrade Recall

    CareFusion recalls 7,914 units of BD Pyxis automated medication dispensing systems after firmware was inadvertently downgraded during installation, potentially causing drawer failures and medication delivery delays.

    Product
    BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2023·2023-03-22

    Medical Device Apheresis Kit Recalled Due to Stress Leak Risk

    Fenwal Inc is recalling 6,564 units in certain lots of Amicus apheresis kits because centrifuge packs may develop a stress leak. No illnesses or injuries have been reported.

    Product
    Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2023·2023-02-15

    RipCord Syndesmosis Button suture may break during orthopedic surgery

    The RipCord Syndesmosis Button's pull suture can break when excessive tension is applied during orthopedic surgery. TriMed Inc. is recalling 76 units due to this structural failure risk.

    Product
    RipCord Syndesmosis Button, REF: STA001K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2023·2023-02-08

    Medline UNITE Foot & Ankle Drill Bit Recalled for Intra-operative Screw Failure Risk

    Medline Industries recalls 190 UNITE foot and ankle drill bits due to observed screw failure during surgery. When used to pre-drill holes for certain screw sizes, the drill bits may fail under surgical torque, creating risk during procedures.

    Product
    MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
    Category
    Medical Device
    Distribution
    Distributed nationwide