Recalls by device type
Every FDA device category with 5+ recalls on record since 2025, from openFDA enforcement reports.
- Device types tracked
- 207
- Recalls across them
- 3,493
- Class I share
- 14%
Most-recalled device types
- Interventional Fluoroscopic X-Ray System17620 Class I
- Nuclear Magnetic Resonance Imaging System14619 Class I
- Intravascular Administration Set1194 Class I
- General Surgery Tray10822 Class I
- Ultrasonic Pulsed Doppler Imaging System82
- Mobile X-Ray System55
- Computed Tomography X-Ray System55
- Computer Controlled Instrument Surgical System551 Class I
- Endoscopic (With Or Without Accessories) Electrosurgical Unit536 Class I
All device types
207
50+ recalls
- Interventional Fluoroscopic X-Ray System176
- Nuclear Magnetic Resonance Imaging System146
- Intravascular Administration Set119
- General Surgery Tray108
- Ultrasonic Pulsed Doppler Imaging System82
- Mobile X-Ray System55
- Computed Tomography X-Ray System55
- Computer Controlled Instrument Surgical System55
- Endoscopic (With Or Without Accessories) Electrosurgical Unit53
- Cardiovascular Procedure Kit52
- Infusion Pump51
10–49 recalls
- Patient(With Arrhythmia Detection Or Alarms) Physiological Monitor48
- Anesthesia Table And Tray Cabinet43
- Radiological Image Processing System41
- Blood-Gases (Pco2, Po2) And Blood Ph Electrode Measurement40
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System40
- Gastrointestinal (And Accessories) Tubes39
- Cutting & Coagulation & Accessories Electrosurgical39
- Diagnostic Ultrasonic Transducer38
- Bone Fixation Plate37
- Reprocessed Electrode Recording Catheter36
- Radiation Therapy Treatment Planning System35
- I.V. Set Stopcock35
- Orthopedic Tray35
- For Clinical Use Chemistry (Photometric, Discrete) Analyzer34
- Emission Computed Tomography System32
- Bronchoscope (Flexible Or Rigid)31
- Metal/Polymer Cemented Constrained Femorotibial Knee Prosthesis31
- Cardiac Catheterization Kit31
- Unscented Menstrual Tampon30
- Laparoscopy Kit27
- Neurological Tray26
- Pacemaker (Non-Crt) Implantable Pulse Generator26
- Diagnostic Intravascular Catheter26
- Nose And Throat Surgical Tray Ear26
- Anesthesia Gas-Machine25
- Ultrasonic Surgical Instrument24
- Trephines & Accessories (Simple, Powered) Burrs Drills24
- Intramedullary And Accessories Fixation Rod24
- Automated External Defibrillators (Non-Wearable)22
- Orthopedic Stereotaxic Instrument22
- Facility Use Continuous Ventilator22
- Arrhythmia Detector And Alarm21
- Angiography/Angioplasty Kit21
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis20
- Central Venous Catheter Tray20
- Gynecological Laparoscopic Kit20
- Dressing Change Tray20
- Factory Calibrated Integrated Continuous Glucose Monitoring System19
- Eye Tray19
- Reverse Configuration Shoulder Prosthesis19
- Epidural Anesthesia Kit19
- Resectoscope18
- Plastic Surgery And Accessories Kit18
- Labor And Delivery Kit18
- Percutaneous Catheter17
- Drug Wound Dressing17
- For Endoscope Cleaning Accessories17
- Disposable Surgical Instrument Kit17
- Short-Term Less Than 30 Days Therapeutic Intravascular Catheter17
- Obstetrical Kit16
- Cardiopulmonary Bypass Vascular Cannula And Tubing Catheter16
- Endosseous Dental Implant Abutment16
- Catheter Introducer16
- Cesarean Section Tray15
- Breathing (W Connector, Adaptor, Y Piece) Circuit15
- Ct Biopsy Tray15
- Spinal Epidural Anesthesia Kit15
- High Permeability With Or Without Sealed Dialysate System Dialyzer15
- Flexible/Rigid Ureteroscope And Accessories14
- Radioallergosorbent (Rast) Immunological Test System14
- Absorbable Synthetic Nose And Throat Ear Polymer14
- Laparoscopic Insufflator14
- Alternate Controller Enabled Insulin Infusion Pump14
- Differential Cell Counter14
- Intravascular Subcutaneous Implanted Port & Catheter14
- Blood Collection Serum Separators Systems Vials Tubes14
- Hysterectomy Kit14
- I.V. Start Kit14
- Capillary Blood Collection Tube13
- Anesthesia Conduction Kit13
- Gaseous-Phase Carbon-Dioxide Gas Analyzer13
- Protective Apron13
- Ophthalmic Forceps13
- Implanted Hemodialysis Catheter13
- Surgical Tray12
- Patient (Without Arrhythmia Detection Or Alarms) Physiological Monitor12
- Medical Linear Accelerator12
- To Be Used With Invasive Glucose Sensor Insulin Infusion Pump12
- Powered Laser Surgical Instrument12
- Temporary Non-Roller Type Left Heart Support Blood Pump11
- Accessories Cryosurgical Unit11
- Ventricular (Assist) Bypass11
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)11
- Reprocessed Laparoscopic & Endoscopic Cutting & Coagulation Accessories Electrosurgical11
- Thermal Regulating System11
- Piston Syringe11
- Tissue Expander And Accessories10
- Stationary X-Ray System10
- Hydro-Massage Bath10
- Endoscope Introducer Kit10
- Oximeter10
- Non-Ac-Powered Patient Lift10
Under 10 recalls
- Ophthalmic Knife9
- Lumbar Intervertebral Fusion Device With Bone Graft9
- Porous Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis9
- Adhesive Tape And Bandage9
- Lumbar Intervertebral Fusion Device With Integrated Fixation9
- Non-Implanted Triple Lumen Hemodialysis Catheter9
- Drains And Dilators For The Biliary Ducts Stents8
- Long-Term Greater Than 30 Days Therapeutic Intravascular Catheter8
- Quality Control For Culture Media Kit8
- Tracheobronchial Suction Catheters8
- Cemented Metal/Polymer Semi-Constrained Hip Prosthesis8
- Uncemented Cemented Or Non-Porous Metal/Ceramic/Polymer Semi-Constrained Hip Prosthesis8
- Ultrasonic Pulsed Echo Imaging System8
- Soft Tissue Biodegradable Fixation Fastener8
- Somatic Or Germline Variant Detection System Next Generation Sequencing Oncology Panel8
- Reprocessed Atherectomy Catheter8
- With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator8
- Wound Dressing Kit8
- Tympanostomy Tube8
- Carotid Stent8
- Intra-Aortic And Control Balloon System8
- Nerve Block Tray8
- Powered Wheelchair7
- Reprocessed Intravascular Ultrasound Catheter7
- Immunoassay Blood Test For Amyloid Pathology Assessment7
- Catheter Guide Wire7
- Catheter Care Tray7
- General Purpose Dental Tray7
- Infusion Safety Management Software7
- Calcium Compound Bone Void Filler7
- Breathing-Circuit Bacterial Filter7
- Ceiling Mounted Surgical Light7
- Programmable Implanted Infusion Pump7
- Flexible/Rigid Duodenoscope And Accessories7
- Non-Heated Anesthesia Vaporizer7
- Rigid Laryngoscope7
- With And Without Anti-Regurgitation Valve Blood Tubing Set7
- Inflatable Penis Prosthesis7
- Angiographic Injector And Syringe7
- Single Hormonal Control Automated Insulin Dosing Device System7
- Irrigation Catheter7
- Therapeutic Heating Infrared Lamp6
- Circumcision Tray6
- Gastro-Urology Evacuator6
- Image-Intensified Fluoroscopic X-Ray System6
- General Purpose Reagent6
- Wheelchair Components6
- Tube Tracheostomy And Tube Cuff6
- Blood Pressure Cuff6
- Wound Dressing With Animal-Derived Material(S)6
- Multi-Analyte Controls Unassayed6
- Umbilical Artery Catheter6
- Surgical Retainer6
- Adjustable Home-Use Ac-Powered Therapeutic Bed6
- Catheter Cannula6
- Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples6
- Over The Counter Blood Glucose Test System6
- For Treatment Of Atrial Fibrillation Cardiac Ablation Percutaneous Catheter6
- Arthrogram Tray6
- Endosseous Dental Implant Accessories6
- Metal/Polymer Cemented Semi-Constrained Shoulder Prosthesis6
- Ac-Powered Surgical With Orthopedic Accessories Table6
- Flow Cytometric Reagents And Accessories.6
- Bone Fixation Screw6
- Antimicrobial Surgical Drape6
- Streptococcus Spp. All Groups Antigens6
- Blood And Urine Collection Kit (Excludes Hiv Testing)6
- Selective And Differential Culture Media6
- Cardiopulmonary Bypass Fitting Manifold Stopcock Adaptor6
- General & Plastic Surgery Laparoscope6
- Foley Catheter Kit (Excludes Hiv Testing)6
- Pneumatic Tourniquet6
- Infusion Fluid Thermal Warmer5
- Electrocardiograph5
- Surgical Gown5
- Anesthesia Breathing Circuit Kit (Adult & Pediatric)5
- Temporary Non-Roller Type Right Heart Support Blood Pump5
- Rebasing Repairing Relining Denture Resin5
- Gastroenterology-Urology Endoscopic Access Overtube5
- Radiologic Table5
- Portable Oxygen Generator5
- Mammographic X-Ray System Full Field Digital5
- Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System5
- Ultrasonic Lithotriptor5
- Intermittent Positive Pressure Breathing Device5
- Root-Form Endosseous Implant5
- Orthopedic Manual Surgical Instrument5
- Not For Use With Automated Insulin Delivery Systems Factory Calibrated Integrated Continuous Glucose Monitoring System5
- Sterile Specimen Container5
- Polydioxanone Absorbable Surgical Suture5
- Potassium Ion Specific Electrode5
- Exempt Surgical Drape5
- Perinatal Monitoring System5
- Implantable Radiographic Marker5
- Thoracolumbosacral Pedicle Screw System5
- Chest Drainage Kit5
- Emergency Response Safety Kit5
- Laceration Tray5
- Medical Devices Disinfector5
- Totally Implanted For Pain Relief Spinal-Cord Stimulator5
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents5
- Patient Personal Hygiene Kit5
- All Kinds (Assayed) Multi-Analyte Controls5
- Balloon Inflation Syringe5