Companies with the most medical device recalls

The 100 companies with the most FDA device recalls, how many of those recalls name a 510(k), and their clearance counts.

#	Company	Recalls	12 mo	Name a 510(k)	510(k)s
1	Boston Scientific Corporation	1,256	49	852	734
2	Siemens Medical Solutions USA, Inc.	1,245	19	1,199	834
3	Zimmer, Inc.	1,073	26	689	423
4	Zimmer Biomet, Inc.	875	0	645	6
5	MEDLINE INDUSTRIES, LP - Northfield	812	0	72	0
6	GE Healthcare, LLC	793	9	684	169
7	Siemens Healthcare Diagnostics, Inc.	768	15	645	246
8	Baxter Healthcare Corp	753	19	569	569
9	Depuy Orthopaedics, Inc.	740	0	488	210
10	Medline Industries, LP	723	577	111	269
11	Arrow International Inc	708	47	609	22
12	Customed, Inc	699	0	108	37
13	ICU Medical, Inc.	656	25	583	72
14	Cook, Inc.	650	25	381	365
15	Beckman Coulter Inc.	648	23	486	279
16	Biomerieux Inc	635	4	234	275
17	Covidien LLC	576	15	502	225
18	Terumo Cardiovascular Systems Corporation	571	0	503	74
19	Philips North America Llc	565	102	513	1
20	Biomet, Inc.	547	5	386	445
21	Stryker Howmedica Osteonics Corp.	528	0	360	1
22	B. Braun Medical, Inc.	510	138	350	152
23	Becton Dickinson & Company	499	17	308	199
24	Smiths Medical ASD, Inc.	474	0	307	52
25	Smith & Nephew, Inc.	448	2	331	550
26	Stryker Instruments Div. of Stryker Corporation	448	0	362	0
27	Olympus Corporation of the Americas	423	125	404	1
28	Philips Medical Systems (Cleveland) Inc	414	0	404	190
29	Ortho-Clinical Diagnostics	354	0	287	144
30	Windstone Medical Packaging, Inc.	337	22	1	0
31	Medtronic, Inc.	328	7	222	247
32	Integra LifeSciences Corp.	316	0	256	94
33	The Anspach Effort, Inc.	303	0	259	60
34	Cardinal Health 200, LLC	303	30	90	4
35	Teleflex Medical	303	0	219	45
36	Merit Medical Systems, Inc.	301	19	208	181
37	Hospira Inc.	290	0	273	45
38	Centurion Medical Products Corporation	286	0	40	3
39	Stryker Endoscopy	278	0	62	103
40	Intuitive Surgical, Inc.	277	17	273	198
41	Maquet Cardiovascular, LLC	271	1	254	14
42	Abbott Laboratories	267	2	209	890
43	Howmedica Osteonics Corp.	251	20	224	301
44	Biomet 3i, LLC	245	0	199	32
45	Roche Diagnostics Corp.	240	0	191	462
46	Bard Peripheral Vascular Inc	237	3	211	39
47	DeRoyal Industries Inc	236	2	32	92
48	GE Medical Systems, LLC	235	23	200	329
49	Medtronic Vascular	234	0	214	480
50	Resource Optimization & Innovation Llc	228	0	9	0
51	Exactech, Inc.	221	5	184	186
52	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	218	84	193	107
53	American Contract Systems Inc	213	10	0	0
54	AVID Medical, Inc.	210	65	0	2
55	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	198	0	6	0
56	Beaver Visitec International, Inc.	195	1	6	1
57	Stryker Corporation	192	18	168	352
58	Encore Medical, Lp	189	7	145	85
59	Medtronic Neuromodulation	184	7	7	1
60	Atrium Medical Corporation	180	3	151	69
61	Philips Medical Systems	180	5	176	221
62	Conmed Corporation	178	12	153	83
63	Ethicon Endo-Surgery, Inc.	178	0	106	186
64	CareFusion 303, Inc.	175	13	90	7
65	Medtronic Sofamor Danek USA, Inc.	174	3	118	437
66	C.R. Bard, Inc.	173	11	141	655
67	Edwards Lifesciences, LLC	171	1	148	158
68	Philips Healthcare Inc.	170	0	157	1
69	Synthes (USA) Products LLC	164	2	108	61
70	Philips Electronics North America Corporation	163	0	149	0
71	Elekta, Inc.	162	11	161	22
72	Fresenius Medical Care Holdings, Inc.	162	4	148	0
73	Cardinal Health	161	0	91	28
74	Datascope Corp.	155	7	138	136
75	STERIS Corporation	152	16	105	228
76	Roche Diagnostics Operations, Inc.	151	2	115	7
77	TELEFLEX LLC	151	1	145	11
78	Cordis Corp.	146	0	49	328
79	Valorem Surgical LLC	144	0	144	1
80	Medtronic Perfusion Systems	141	24	132	29
81	Philips Ultrasound, Inc	141	15	141	78
82	Wright Medical Technology Inc	141	1	117	1
83	Argon Medical Devices, Inc	137	9	109	25
84	Angiodynamics, Inc.	135	20	114	90
85	Sorin Group USA, Inc.	135	0	130	2
86	Mckesson Medical-Surgical Inc. Corporate Office	119	0	59	0
87	RAYSEARCH LABORATORIES AB	117	11	111	7
88	Carefusion 2200 Inc	114	0	73	14
89	Aomori Olympus Co., Ltd.	113	0	106	7
90	Medtronic Navigation, Inc.	113	4	109	44
91	Remel Co.	113	4	57	164
92	Alcon Research LLC	111	2	43	17
93	Ameditech Inc	111	0	105	14
94	Stryker Neurovascular	109	1	101	34
95	ETHICON, Inc.	106	2	88	208
96	Instrumentation Laboratory CO	106	32	103	327
97	Draeger Medical, Inc.	103	0	62	94
98	Stryker Medical Division of Stryker Corporation	101	3	10	0
99	Medtronic Minimed	99	26	29	57
100	Stryker Spine	99	0	56	75

More: Medical device recalls by FDA device class · Recalls within a year of 510(k) clearance · Most recalled device types by review panel · 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