The Recall Desk

Hazard

Device Failure recalls

240 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 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 240

  • 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-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
  • 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
  • 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
  • HighFDA (Devices)·Z-0921-2023·2023-01-18

    Adult Craniotome Ball Bearing Separation Risk During Neurosurgery

    The Anspach Adult Craniotome Large attachment ball bearings may separate during surgical removal or intra-operatively, potentially causing serious patient injury.

    Product
    Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2023·2023-01-18

    Anspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery

    The Anspach Adult Rotating Craniotome Attachment (CRANI-A-R) may have ball bearings that detach during surgical use. The FDA recommends users follow inspection intervals to prevent potential serious patient injury.

    Product
    6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2023·2023-01-11

    DeRoyal Tonsillectomy Tray recalled for potential suction port occlusion

    DeRoyal is recalling certain Tonsillectomy Tray lots due to potential blockage of suction ports in the integrated electrosurgical suction coagulator. The defect may prevent proper suction function during surgical procedures.

    Product
    DeRoyal Tonsillectomy Tray, REF 89-10698.01
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0449-2023·2022-12-21

    Intra-Aortic Balloon Pump with Potential Short Battery Run-Times

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pumps are being recalled worldwide due to short battery run-times affecting device operation. Patients using this device should contact their healthcare provider immediately.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0444-2023·2022-12-21

    Arrow AutoCAT 2 Intra-Aortic Balloon Pump Short Battery Runtime Recall

    Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP) due to a potential issue with short battery run-times. The recall affects 29 units distributed worldwide.

    Product
    Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0446-2023·2022-12-21

    Arrow AutoCAT 2 Cardiac Pump Recalled for Battery Runtime Issues

    Arrow AutoCAT 2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. Affected users should contact the manufacturer for guidance.

    Product
    Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0440-2023·2022-12-21

    Arrow AC3 Optimus intra-aortic balloon pump short battery runtime

    Arrow AC3 Optimus cardiac pumps may experience short battery run-times. The FDA has issued a Class I recall for all units worldwide.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0428-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times

    Arrow AutoCAT2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The recall affects 12 units distributed worldwide.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0433-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Battery Run-Time Issue

    Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0477-2023·2022-12-21

    Surgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown

    Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.

    Product
    Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2023·2022-12-21

    Intra-Aortic Balloon Pump Recalled for Potential Battery Run-Time Issue

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0338-2023·2022-12-14

    FDA Class I Recall: CAIRE Liberator 30 Liquid Oxygen System Units

    Caire, Inc. is recalling five CAIRE Liberator 30 liquid oxygen system units due to weld defects on the inner bottle that could lead to device failure and loss of oxygen supply to dependent patients.

    Product
    CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide