Medical device recalls by FDA device class

How recalls split across Class I, II and III devices, the recall-to-clearance ratio per class, and the product codes with the most recalls in each.

Class	Codes	510(k)s	Recalls	Recalls, 12 mo	Recalls per 100 510(k)s
Class I	1,770	32,837	9,898	566	30.1
Class II	3,105	137,494	44,230	2,413	32.2
Class III	242	1,463	3,703	122	253.1

Class III devices mostly go through PMA, not 510(k), so their ratio is high by construction. Device class comes from the FDA product code file.

Class I: codes with the most recalls

Code	Device	Recalls	12 mo	510(k)s
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	564	10	208
LXH	Orthopedic Manual Surgical Instrument	526	8	58
KDD	Kit, Surgical Instrument, Disposable	252	16	62
OJH	Orthopedic Tray	239	35	0
JQP	Calculator/Data Processing Module, For Clinical Use	218	2	78
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	205	14	184
HNN	Knife, Ophthalmic	155	1	54
FSA	Lift, Patient, Non-Ac-Powered	143	10	13
HTW	Bit, Drill	114	2	11
KCY	Tourniquet, Pneumatic	112	70	34
LRP	Tray, Surgical	111	11	22
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	107	0	96
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	101	0	76
BRY	Cabinet, Table And Tray, Anesthesia	99	10	5
JJY	Multi-Analyte Controls, All Kinds (Assayed)	95	2	673
OJG	Neurological Tray	94	24	0
NJT	Immunohistochemistry Reagents And Kits	92	1	0
BSY	Catheters, Suction, Tracheobronchial	89	0	116
HWT	Template	85	0	10
GBX	Catheter, Irrigation	83	7	77
HTO	Reamer	83	0	14
MDM	Instrument, Manual, Surgical, General Use	77	1	44
OGR	Ear, Nose, And Throat Surgical Tray	77	24	0
CAE	Airway, Oropharyngeal, Anesthesiology	76	3	57
MDB	System, Blood Culturing	76	0	68

Code	Device	Recalls	12 mo	510(k)s
FPA	Set, Administration, Intravascular	1,090	110	1,176
LRO	General Surgery Tray	1,084	103	110
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	985	7	921
JAK	System, X-Ray, Tomography, Computed	872	38	827
FRN	Pump, Infusion	724	24	849
LNH	System, Nuclear Magnetic Resonance Imaging	723	60	1,110
HSB	Rod, Fixation, Intramedullary And Accessories	690	19	532
GEI	Electrosurgical, Cutting & Coagulation & Accessories	644	18	2,320
OWB	Interventional Fluoroscopic X-Ray System	638	110	325
DQY	Catheter, Percutaneous	620	2	896
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	563	20	403
IYE	Accelerator, Linear, Medical	563	8	738
LLZ	System, Image Processing, Radiological	562	25	2,295
FSY	Light, Surgical, Ceiling Mounted	454	5	74
FGE	Stents, Drains And Dilators For The Biliary Ducts	452	12	478
KPS	System, Tomography, Computed, Emission	450	9	473
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	394	6	508
DYB	Introducer, Catheter	389	27	707
HWC	Screw, Fixation, Bone	389	7	1,070
CBK	Ventilator, Continuous, Facility Use	336	23	505
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	332	9	303
FMI	Needle, Hypodermic, Single Lumen	311	3	694
FMF	Syringe, Piston	305	4	752
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	300	4	1,189
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	299	3	565

Code	Device	Recalls	12 mo	510(k)s
MKJ	Automated External Defibrillators (Non-Wearable)	338	4	228
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	269	0	0
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	219	1	0
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	203	0	114
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	176	2	0
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	153	0	0
LKK	Pump, Infusion, Implanted, Programmable	132	2	0
DSQ	Ventricular (Assist) Bypass	131	8	0
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	113	1	0
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	96	4	0
NIP	Stent, Superficial Femoral Artery	86	0	0
MIE	Heart-Valve, Allograft	80	0	0
DXY	Implantable Pacemaker Pulse-Generator	75	0	461
HQL	Intraocular Lens	75	1	5
MDS	Sensor, Glucose, Invasive	57	0	0
OZD	Temporary Non-Roller Type Left Heart Support Blood Pump	50	14	0
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	46	2	0
NVZ	Pulse Generator, Permanent, Implantable	43	3	0
LYJ	Stimulator, Autonomic Nerve, Implanted For Epilepsy	37	0	0
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	36	3	0
MRM	Defibrillator, Implantable, Dual-Chamber	34	0	0
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	34	0	0
OYC	Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor	34	6	0
MCM	Implant, Cochlear	33	4	0
NRA	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing	32	0	0