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.

826–850 of 881

  • HighFDA (Devices)·Z-1569-2013·2013-07-03

    Terumo Recalls Sarns TCM II Temperature Control Modules Due to Assembly Defect

    Terumo is recalling seven Sarns TCM II Temperature Control Modules because internal testing found incorrectly assembled heatsinks that could cause unit failure.

    Product
    Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1534-2013·2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    Product
    90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Spe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2013·2013-06-12

    American Optisurgical Recalls TX1 Tissue Removal System Consoles

    American Optisurgical is recalling 194 TX1 Tissue Removal System Consoles due to a defect in the overheating protection circuit that may cause the device to lose power during use.

    Product
    American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1509-2013·2013-06-12

    Cordis Recalls FLEXSTENT Biliary Stents Due to Pouch Defects

    Cordis is recalling 1,357 FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.

    Product
    FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1185-2013·2013-05-08

    Medi-Trace Pediatric Defibrillation Electrodes Recalled for Arcing Risk

    FDA is recalling Medi-Trace Cadence Pediatric Defibrillation Electrodes because arcing or sparking may damage the leadwire, preventing the device from delivering appropriate energy to patients.

    Product
    Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1189-2013·2013-05-08

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Therapy Failure Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver defibrillation therapy in Manual Defib or AED mode.

    Product
    HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2013·2013-05-08

    Medi-Trace Cadence Adult Defibrillation Electrodes Recalled for Thermal Damage Risk

    FDA is recalling Medi-Trace Cadence Adult Defibrillation Electrodes because arcing or sparking may cause thermal damage to the leadwire, potentially preventing the device from delivering appropriate energy to patients.

    Product
    Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2013·2013-04-17

    Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits

    Arrow International is recalling 637 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.

    Product
    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1082-2013·2013-04-17

    Physio Control Recalls LIFEPAK Defibrillators Due to Battery Depletion Risk

    Physio Control is recalling LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators because they may experience early internal battery depletion.

    Product
    The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1064-2013·2013-04-17

    Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits

    Arrow International is recalling 188 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.

    Product
    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0954-2013·2013-03-27

    Biomet Spine Polaris Screw Inserter Recalled for Tip Failure Risk

    Ebi, LLC is recalling 59 units of the Biomet Spine Polaris 5.5 Button Lock Screw Inserter due to an increased risk of failure at the driver tip during use.

    Product
    Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2013·2013-03-27

    DePuy ReClaim Reamer Extension Recalled Due to Broken Tabs

    DePuy Orthopaedics is recalling 750 ReClaim Reamer Extension devices because tabs may break and remain in patients during surgery.

    Product
    ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
    Category
    Medical Device
    Distribution
    27 states
  • SevereFDA (Devices)·Z-0928-2013·2013-03-20

    Sorin Isoline Implantable Defibrillation Leads Recalled for Insulation Breach

    Sorin Group USA is recalling 1,376 Isoline implantable defibrillation leads due to potential internal insulation breaches. The leads are used for treating life-threatening heart arrhythmias.

    Product
    Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2013·2013-03-06

    Orthofix ISKD Limb Lengthener Recalled for Potential Post-Operative Failure

    Orthofix, Inc. is recalling ISKD limb lengtheners because the device may stop distracting after surgery, potentially causing premature bone consolidation and the need for revision surgery.

    Product
    Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2013·2013-02-27

    Philips HeartStart XL+ Defibrillators Recalled for Potential Lockout

    Philips is recalling 3,785 HeartStart XL+ defibrillators because they may become locked out of clinical use.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0763-2013·2013-02-20

    St. Jude Medical Recalls TorqVue FX Delivery Systems Due to Fracture Risk

    St. Jude Medical is recalling 635 TorqVue FX Delivery Systems because the core wire could fracture during use.

    Product
    St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2013·2013-02-13

    Medacta Quadra Trial Broach size 0 recalled due to tip breakage

    Medacta USA Inc. is recalling 26 units of the Quadra Trial Broach size 0 because the tip broke during surgery.

    Product
    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0711-2013·2013-01-30

    DePuy Spine VIPER Polyaxial Screws Recalled for Potential Disassociation

    DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.

    Product
    DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2013·2013-01-23

    Stryker Recalls Hoffman LRF Wire Bolts Due to Breakage During Use

    Stryker Howmedica Osteonics is recalling 476 Hoffman LRF Wire Bolts because two complaints reported the wires broke during load-bearing application by patients.

    Product
    Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2013·2013-01-16

    Concentric Medical Recalls FlowGate Balloon Guide Catheters Due to Tip Collapse

    Concentric Medical is recalling 13 FlowGate Balloon Guide Catheters after reports of resistance and possible distal tip collapse during use.

    Product
    FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0658-2013·2013-01-16

    Zoll AutoPulse Resuscitation System Recalled for Unexpected Compression Stops

    Zoll Circulation is recalling AutoPulse Model 100 systems because they may stop compressions unexpectedly during use.

    Product
    AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spont
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0549-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Broach and Related Tools

    Zimmer, Inc. is recalling 92 units of Persona Knee System Tibial Broaches and related tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Coll
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0553-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates due to a risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0542-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk

    Zimmer, Inc. is recalling Persona knee implants and associated tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide