Recalls by device type
Every FDA device category with 5+ recalls on record since 2025, from openFDA enforcement reports.
- Device types tracked
- 220
- Recalls across them
- 3,790
- Class I share
- 14%
Most-recalled device types
- Interventional Fluoroscopic X-Ray System18420 Class I
- Nuclear Magnetic Resonance Imaging System14619 Class I
- General Surgery Tray12724 Class I
- Intravascular Administration Set1215 Class I
- Ultrasonic Pulsed Doppler Imaging System82
- Cardiovascular Procedure Kit6313 Class I
- Computed Tomography X-Ray System59
- Mobile X-Ray System58
- Computer Controlled Instrument Surgical System561 Class I
All device types
220
50+ recalls
- Interventional Fluoroscopic X-Ray System184
- Nuclear Magnetic Resonance Imaging System146
- General Surgery Tray127
- Intravascular Administration Set121
- Ultrasonic Pulsed Doppler Imaging System82
- Cardiovascular Procedure Kit63
- Computed Tomography X-Ray System59
- Mobile X-Ray System58
- Computer Controlled Instrument Surgical System56
- Endoscopic (With Or Without Accessories) Electrosurgical Unit53
- Infusion Pump53
10–49 recalls
- Patient(With Arrhythmia Detection Or Alarms) Physiological Monitor49
- Blood-Gases (Pco2, Po2) And Blood Ph Electrode Measurement48
- Radiological Image Processing System46
- Orthopedic Tray44
- Cutting & Coagulation & Accessories Electrosurgical43
- Anesthesia Table And Tray Cabinet43
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System40
- Gastrointestinal (And Accessories) Tubes39
- Diagnostic Ultrasonic Transducer38
- Bone Fixation Plate37
- Reprocessed Electrode Recording Catheter36
- Cardiac Catheterization Kit36
- For Clinical Use Chemistry (Photometric, Discrete) Analyzer36
- I.V. Set Stopcock35
- Radiation Therapy Treatment Planning System35
- Metal/Polymer Cemented Constrained Femorotibial Knee Prosthesis33
- Catheter Introducer33
- Neurological Tray32
- Emission Computed Tomography System32
- Bronchoscope (Flexible Or Rigid)31
- Unscented Menstrual Tampon30
- Nose And Throat Surgical Tray Ear30
- Laparoscopy Kit28
- Gynecological Laparoscopic Kit27
- Diagnostic Intravascular Catheter26
- Anesthesia Gas-Machine26
- Pacemaker (Non-Crt) Implantable Pulse Generator26
- Trephines & Accessories (Simple, Powered) Burrs Drills24
- Ultrasonic Surgical Instrument24
- Facility Use Continuous Ventilator24
- Cardiopulmonary Bypass Vascular Cannula And Tubing Catheter24
- Intramedullary And Accessories Fixation Rod24
- Orthopedic Stereotaxic Instrument23
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis23
- Automated External Defibrillators (Non-Wearable)22
- Angiography/Angioplasty Kit22
- Powered Wheelchair22
- Arrhythmia Detector And Alarm21
- Eye Tray21
- Central Venous Catheter Tray20
- Reverse Configuration Shoulder Prosthesis20
- Epidural Anesthesia Kit20
- Dressing Change Tray20
- Plastic Surgery And Accessories Kit19
- Factory Calibrated Integrated Continuous Glucose Monitoring System19
- Obstetrical Kit19
- Resectoscope18
- Drug Wound Dressing18
- Labor And Delivery Kit18
- Percutaneous Catheter18
- Disposable Surgical Instrument Kit17
- Alternate Controller Enabled Insulin Infusion Pump17
- Short-Term Less Than 30 Days Therapeutic Intravascular Catheter17
- Patient (Without Arrhythmia Detection Or Alarms) Physiological Monitor17
- Cesarean Section Tray17
- High Permeability With Or Without Sealed Dialysate System Dialyzer17
- For Endoscope Cleaning Accessories17
- Endosseous Dental Implant Abutment17
- Breathing (W Connector, Adaptor, Y Piece) Circuit16
- Spinal Epidural Anesthesia Kit16
- Hysterectomy Kit15
- Ct Biopsy Tray15
- Laparoscopic Insufflator15
- Flexible/Rigid Ureteroscope And Accessories14
- Differential Cell Counter14
- Absorbable Synthetic Nose And Throat Ear Polymer14
- Thermal Regulating System14
- Blood Collection Serum Separators Systems Vials Tubes14
- Intravascular Subcutaneous Implanted Port & Catheter14
- Radioallergosorbent (Rast) Immunological Test System14
- I.V. Start Kit14
- Anesthesia Conduction Kit13
- Orthopedic Manual Surgical Instrument13
- Implanted Hemodialysis Catheter13
- Protective Apron13
- Gaseous-Phase Carbon-Dioxide Gas Analyzer13
- Ophthalmic Forceps13
- Capillary Blood Collection Tube13
- Accessories Cryosurgical Unit12
- Surgical Tray12
- Multiple Component Nail/Blade/Plate Combination Fixation Appliance12
- To Be Used With Invasive Glucose Sensor Insulin Infusion Pump12
- Powered Laser Surgical Instrument12
- Medical Linear Accelerator12
- Reprocessed Laparoscopic & Endoscopic Cutting & Coagulation Accessories Electrosurgical11
- Piston Syringe11
- Ventricular (Assist) Bypass11
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)11
- Temporary Non-Roller Type Left Heart Support Blood Pump11
- Tissue Expander And Accessories10
- Endoscope Introducer Kit10
- Gastro-Urology Evacuator10
- Long-Term Greater Than 30 Days Therapeutic Intravascular Catheter10
- Stationary X-Ray System10
- Drains And Dilators For The Biliary Ducts Stents10
- Non-Ac-Powered Patient Lift10
- Hydro-Massage Bath10
- Oximeter10
Under 10 recalls
- Somatic Or Germline Variant Detection System Next Generation Sequencing Oncology Panel9
- Soft Tissue Biodegradable Fixation Fastener9
- Carotid Stent9
- Electrocardiograph9
- Adhesive Tape And Bandage9
- Nerve Block Tray9
- Porous Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis9
- Lumbar Intervertebral Fusion Device With Integrated Fixation9
- Lumbar Intervertebral Fusion Device With Bone Graft9
- Ophthalmic Knife9
- Non-Implanted Triple Lumen Hemodialysis Catheter9
- Calcium Compound Bone Void Filler8
- Ultrasonic Pulsed Echo Imaging System8
- Cemented Metal/Polymer Semi-Constrained Hip Prosthesis8
- Single Hormonal Control Automated Insulin Dosing Device System8
- Uncemented Cemented Or Non-Porous Metal/Ceramic/Polymer Semi-Constrained Hip Prosthesis8
- Tracheobronchial Suction Catheters8
- Flexible/Rigid Duodenoscope And Accessories8
- Intra-Aortic And Control Balloon System8
- In Situ Polymerizing Peripheral Nerve Repair Device8
- Tympanostomy Tube8
- Quality Control For Culture Media Kit8
- With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator8
- Catheter Guide Wire8
- Wound Dressing Kit8
- Reprocessed Atherectomy Catheter8
- Infusion Safety Management Software7
- General Purpose Dental Tray7
- Programmable Implanted Infusion Pump7
- Immunoassay Blood Test For Amyloid Pathology Assessment7
- Rigid Laryngoscope7
- Wheelchair Components7
- With And Without Anti-Regurgitation Valve Blood Tubing Set7
- Catheter Care Tray7
- Thoracolumbosacral Pedicle Screw System7
- Inflatable Penis Prosthesis7
- Breathing-Circuit Bacterial Filter7
- Ceiling Mounted Surgical Light7
- Angiographic Injector And Syringe7
- Irrigation Catheter7
- Non-Heated Anesthesia Vaporizer7
- General & Plastic Surgery Laparoscope7
- Reprocessed Intravascular Ultrasound Catheter7
- Wall Vacuum Powered Operating-Room Suction Apparatus6
- Blood And Urine Collection Kit (Excludes Hiv Testing)6
- Totally Implanted For Pain Relief Spinal-Cord Stimulator6
- Cardiopulmonary Bypass Fitting Manifold Stopcock Adaptor6
- Umbilical Artery Catheter6
- General Purpose Reagent6
- Radiologic Table6
- Circumcision Tray6
- Blood Pressure Cuff6
- Therapeutic Heating Infrared Lamp6
- For Treatment Of Atrial Fibrillation Cardiac Ablation Percutaneous Catheter6
- Wound Dressing With Animal-Derived Material(S)6
- Ac-Powered Surgical With Orthopedic Accessories Table6
- Pneumatic Tourniquet6
- Infusion Fluid Thermal Warmer6
- Multi-Analyte Controls Unassayed6
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation6
- Endosseous Dental Implant Accessories6
- Selective And Differential Culture Media6
- Arthrogram Tray6
- Image-Intensified Fluoroscopic X-Ray System6
- Streptococcus Spp. All Groups Antigens6
- Tube Tracheostomy And Tube Cuff6
- Root-Form Endosseous Implant6
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents6
- Flow Cytometric Reagents And Accessories.6
- Foley Catheter Kit (Excludes Hiv Testing)6
- Metal/Polymer Cemented Semi-Constrained Shoulder Prosthesis6
- Over The Counter Blood Glucose Test System6
- Surgical Retainer6
- Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples6
- Bone Fixation Screw6
- Antimicrobial Surgical Drape6
- Adjustable Home-Use Ac-Powered Therapeutic Bed6
- Catheter Cannula6
- Temporary Non-Roller Type Right Heart Support Blood Pump5
- Polypropylene Synthetic Nonabsorbable Suture5
- Emergency Response Safety Kit5
- Chest Drainage Kit5
- Ultrasonic Lithotriptor5
- Mammographic X-Ray System Full Field Digital5
- Not For Use With Automated Insulin Delivery Systems Factory Calibrated Integrated Continuous Glucose Monitoring System5
- Rebasing Repairing Relining Denture Resin5
- Biopsy Instrument5
- For Clinical Use Calculator/Data Processing Module5
- Patient Personal Hygiene Kit5
- Anesthesiology Oropharyngeal Airway5
- Surgical Gown5
- Intermittent Positive Pressure Breathing Device5
- Intracranial Aneurysm Flow Diverter5
- Short Incubation Antimicrobial Susceptibility Automated Test System5
- Sterile Specimen Container5
- X-Ray Detectable Internal Gauze/Sponge5
- Balloon Inflation Syringe5
- Exempt Surgical Drape5
- Perinatal Monitoring System5
- Medical Devices Disinfector5
- Laceration Tray5
- Anesthesia Breathing Circuit Kit (Adult & Pediatric)5
- Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System5
- Ventilator (W Harness) Tubing And Support Set5
- Implantable Radiographic Marker5
- Gastroenterology-Urology Endoscopic Access Overtube5
- Portable Oxygen Generator5
- Potassium Ion Specific Electrode5
- All Kinds (Assayed) Multi-Analyte Controls5
- Secondary Calibrator5
- Polydioxanone Absorbable Surgical Suture5