FDA recalls × openFDA

Firms with the most FDA recalls

Firms ranked by the number of FDA recalls (all device, drug, and food recalls — aggregated from openFDA), with a Class I (most serious) breakdown.

An organization of public government data, not an official U.S. government site. Aggregates cover collected data, and rankings are based on name-level aggregation.

What the data shows

The top includes large food, drug, and device makers and firms concentrated in specific categories. A high count does not necessarily mean greater danger — it can reflect a wide product range or proactive voluntary recalls. To gauge health-risk severity, the Class I (most serious) breakdown is the better guide.

Top 50 of 60

#	Firm (recalling)	Count
1	Zimmer Biomet, Inc. 3 Class I	875
2	MEDLINE INDUSTRIES, LP - Northfield 72 Class I	822
3	Customed, Inc 412 Class I	682
4	Boston Scientific Corporation 141 Class I	641
5	Garden-Fresh Foods, Inc. 609 Class I	633
6	Siemens Medical Solutions USA, Inc 16 Class I	621
7	ICU Medical, Inc. 17 Class I	607
8	Medline Industries, LP 85 Class I	553
9	Aidapak Services, LLC	538
10	GE Healthcare, LLC 41 Class I	474
11	Attix Pharmaceuticals	470
12	King Bio Inc. 465 Class I	465
13	Siemens Healthcare Diagnostics, Inc. 13 Class I	461
14	Zimmer, Inc. 2 Class I	444
15	Newly Weds Foods Inc 5 Class I	438
16	Baxter Healthcare Corporation 75 Class I	436
17	Arrow International Inc 15 Class I	431
18	Olympus Corporation of the Americas 44 Class I	420
19	FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine 409 Class I	409
20	The Compounding Pharmacy of America 1 Class I	383
21	Biomerieux Inc 10 Class I	370
22	Good Herbs, Inc.	353
23	Windstone Medical Packaging, Inc. 10 Class I	337
24	C & S Wholesale Grocers, Inc.	330
25	Philips North America Llc 4 Class I	323
26	Philips Medical Systems (Cleveland) Inc 5 Class I	313
27	Whole Foods Market 172 Class I	313
28	Main Street Family Pharmacy, LLC 2 Class I	299
29	Cardinal Health 200, LLC 32 Class I	298
30	Blue Bell Creameries, L.P. 290 Class I	294
31	Reser's Fine Foods, Inc. 226 Class I	283
32	Mckesson Medical-Surgical Inc. Corporate Office	276
33	Central Admixture Pharmacy Services, Inc. 39 Class I	275
34	Cook Inc. 40 Class I	262
35	The Anspach Effort, Inc. 2 Class I	261
36	Intuitive Surgical, Inc. 1 Class I	255
37	Biomet, Inc.	255
38	Covidien LLC 6 Class I	253
39	Maquet Cardiovascular, LLC 5 Class I	252
40	Pharmedium Services, LLC 18 Class I	246
41	Hospira Inc. 61 Class I	245
42	Beckman Coulter Inc. 5 Class I	245
43	Howmedica Osteonics Corp.	244
44	Cardinal Health Inc. 7 Class I	240
45	Stryker Endoscopy	238
46	Dole Fresh Vegetables Inc 204 Class I	230
47	DeRoyal Industries Inc 4 Class I	227
48	Resource Optimization & Innovation Llc	224
49	Biomet 3i, LLC	222
50	Smith & Nephew, Inc.	221

Aggregates cover each source's collected data. Names use the original data as-is.

FAQ

What does this ranking show?

Firms with the most FDA recalls, ordered by recall count (devices, drugs, food), with the Class I (most serious) breakdown shown.

Does a high count mean poor quality?

Not necessarily. Counts vary with the number of products, the firm's reporting diligence, and the category. The count measures recall activity, not an absolute safety verdict.

What is the source?

Recall records from FDA open data (openFDA), aggregated in full by firm name.

← Back to rankings