Most recalled device types by review panel
For each FDA review panel, the product codes with the most recalls of all time and in the last 12 months.
| Code | Device | Recalls | 12 mo |
|---|
| CBK | Ventilator, Continuous, Facility Use | 336 | 23 |
| BTR | Tube, Tracheal (W/Wo Connector) | 227 | 1 |
| CAZ | Anesthesia Conduction Kit | 220 | 13 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 205 | 14 |
| BSZ | Gas-Machine, Anesthesia | 177 | 12 |
| Code | Device | Recalls | 12 mo |
|---|
| DQY | Catheter, Percutaneous | 620 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 563 | 20 |
| DYB | Introducer, Catheter | 389 | 27 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 338 | 4 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 294 | 36 |
| Code | Device | Recalls | 12 mo |
|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 564 | 10 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 218 | 2 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 185 | 33 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 171 | 14 |
| NBW | System, Test, Blood Glucose, Over The Counter | 137 | 4 |
| Code | Device | Recalls | 12 mo |
|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | 81 | 0 |
| DKZ | Enzyme Immunoassay, Amphetamine | 24 | 0 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 23 | 0 |
| DOF | Lead, Atomic Absorption | 21 | 5 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 15 | 0 |
| Code | Device | Recalls | 12 mo |
|---|
| NHA | Abutment, Implant, Dental, Endosseous | 225 | 5 |
| DZE | Implant, Endosseous, Root-Form | 212 | 2 |
| JEY | Plate, Bone | 111 | 0 |
| EBF | Material, Tooth Shade, Resin | 71 | 2 |
| NDP | Accessories, Implant, Dental, Endosseous | 57 | 1 |
| Code | Device | Recalls | 12 mo |
|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 160 | 5 |
| OGR | Ear, Nose, And Throat Surgical Tray | 77 | 24 |
| ETN | Stimulator, Nerve | 31 | 0 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 29 | 0 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 15 | 0 |
| Code | Device | Recalls | 12 mo |
|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 452 | 12 |
| GCJ | Laparoscope, General & Plastic Surgery | 274 | 2 |
| MSD | Catheter, Hemodialysis, Implanted | 270 | 8 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 268 | 26 |
| NAY | System, Surgical, Computer Controlled Instrument | 248 | 16 |
| Code | Device | Recalls | 12 mo |
|---|
| FPA | Set, Administration, Intravascular | 1,090 | 110 |
| FRN | Pump, Infusion | 724 | 24 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 394 | 6 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 332 | 9 |
| FMI | Needle, Hypodermic, Single Lumen | 311 | 3 |
| Code | Device | Recalls | 12 mo |
|---|
| LRO | General Surgery Tray | 1,085 | 104 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 644 | 18 |
| FSY | Light, Surgical, Ceiling Mounted | 454 | 5 |
| KDD | Kit, Surgical Instrument, Disposable | 252 | 16 |
| OJH | Orthopedic Tray | 239 | 35 |
| Code | Device | Recalls | 12 mo |
|---|
| GKZ | Counter, Differential Cell | 247 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 103 | 1 |
| NJT | Immunohistochemistry Reagents And Kits | 92 | 1 |
| GJS | Test, Time, Prothrombin | 73 | 0 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 44 | 1 |
| Code | Device | Recalls | 12 mo |
|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 27 | 14 |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 20 | 0 |
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 19 | 0 |
| JZO | System, Test, Thyroid Autoantibody | 18 | 1 |
| MOI | System, Test, Immunological, Antigen, Tumor | 18 | 0 |
| Code | Device | Recalls | 12 mo |
|---|
| OYX | Bcr/Abl1 Monitoring Test | 3 | 2 |
| QDI | Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies | 1 | 0 |
| Code | Device | Recalls | 12 mo |
|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 240 | 6 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 78 | 0 |
| MDB | System, Blood Culturing | 76 | 0 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 56 | 0 |
| JTN | Susceptibility Test Discs, Antimicrobial | 47 | 1 |
| Code | Device | Recalls | 12 mo |
|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 258 | 19 |
| HAW | Neurological Stereotaxic Instrument | 202 | 7 |
| OLO | Orthopedic Stereotaxic Instrument | 115 | 13 |
| JXG | Shunt, Central Nervous System And Components | 108 | 1 |
| OJG | Neurological Tray | 94 | 24 |
| Code | Device | Recalls | 12 mo |
|---|
| OKV | Obstetrical Kit | 95 | 15 |
| OHM | Cesarean Section Tray | 75 | 14 |
| OHD | Gynecological Laparoscopic Kit | 56 | 22 |
| MLS | Labor And Delivery Kit | 47 | 11 |
| HEB | Tampon, Menstrual, Unscented | 36 | 1 |
| Code | Device | Recalls | 12 mo |
|---|
| HNN | Knife, Ophthalmic | 155 | 1 |
| HQL | Intraocular Lens | 75 | 1 |
| HQC | Unit, Phacofragmentation | 74 | 0 |
| OJK | Eye Tray | 74 | 17 |
| LPL | Lenses, Soft Contact, Daily Wear | 71 | 1 |
| Code | Device | Recalls | 12 mo |
|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 985 | 7 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 690 | 19 |
| LXH | Orthopedic Manual Surgical Instrument | 526 | 8 |
| HWC | Screw, Fixation, Bone | 389 | 7 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 299 | 3 |
| Code | Device | Recalls | 12 mo |
|---|
| MVU | Reagents, Specific, Analyte | 43 | 1 |
| KPA | Slide Stainer, Automated | 30 | 0 |
| PPM | General Purpose Reagent | 30 | 4 |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 29 | 9 |
| FMH | Container, Specimen, Sterile | 21 | 3 |
| Code | Device | Recalls | 12 mo |
|---|
| ITI | Wheelchair, Powered | 71 | 17 |
| IOR | Wheelchair, Mechanical | 40 | 0 |
| IOQ | Bed, Flotation Therapy, Powered | 38 | 3 |
| ITJ | Walker, Mechanical | 29 | 2 |
| IMD | Pack, Hot Or Cold, Disposable | 26 | 0 |
| Code | Device | Recalls | 12 mo |
|---|
| JAK | System, X-Ray, Tomography, Computed | 872 | 38 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 723 | 60 |
| OWB | Interventional Fluoroscopic X-Ray System | 638 | 110 |
| IYE | Accelerator, Linear, Medical | 563 | 8 |
| LLZ | System, Image Processing, Radiological | 562 | 25 |
More: Medical device recalls by FDA device class · Recalls within a year of 510(k) clearance · Top 510(k) applicants in the last 12 months · Latest recalls of Class III devices · Latest recalls of Class II devices · Latest recalls of Class I devices · Companies with the most medical device recalls