Medical Device Statistics

Data and trends from 40,358 FDA medical device recalls spanning 1930 to 2026.

0Total Recalls
0Class I (Most Serious)
0Class II
0Voluntary Recalls

Device Recalls by Year

Number of FDA medical device recall enforcement actions per year.

Top Recall Reasons

Most common reasons for FDA device recalls.

#ReasonRecalls
1Other26,101
2Sterility Issues5,797
3Labeling Errors3,232
4Software Issues1,946
5Calibration / Accuracy717
6Packaging Issues623
7Contamination557
8Battery Issues546
9Electrical Failure423
10Manufacturing Defect361
11cGMP Deviations6

Top Recalling Firms

Companies with the most FDA device recall actions.

#FirmRecalls
1Zimmer Biomet, Inc.875
2MEDLINE INDUSTRIES, LP - Northfield812
3Customed, Inc682
4Boston Scientific Corporation642
5Siemens Medical Solutions USA, Inc623
6ICU Medical, Inc.605
7Medline Industries, LP574
8GE Healthcare, LLC474
9Siemens Healthcare Diagnostics, Inc.462
10Zimmer, Inc.444
11Arrow International Inc431
12Olympus Corporation of the Americas423
13Baxter Healthcare Corporation383
14Biomerieux Inc370
15Windstone Medical Packaging, Inc.337

Recalls by State

States where recalling firms are located.

#StateRecalls
1California4,686
2Massachusetts3,550
3Illinois3,367
4Pennsylvania2,984
5Indiana2,561
6N/A2,115
7New Jersey2,093
8Minnesota1,678
9Florida1,518
10New York1,402
11Ohio1,114
12Wisconsin971
13Michigan955
14Missouri931
15Texas818
16Puerto Rico814
17Georgia776
18North Carolina775
19Tennessee755
20Connecticut720

About This Data

All medical device recall data comes from the U.S. FDA through the openFDA enforcement database. Our database contains 40,358 device recall enforcement actions spanning 1930 to 2026.

Class I is the most serious, reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse effects. Class III is least serious, exposure not likely to cause harm. Our database contains 3,664 Class I, 35,653 Class II, and 1,040 Class III.