Firms with the most FDA enforcement events
Siemens Medical Solutions USA, Inc has the most FDA enforcement events: 400, with 796 product records. The 50 firms in the table started 5,396 of the 27,779 events, or 19.4%. FDA events that started in 2025 were 1,836, against 1,772 in 2024, so the count rose by 3.6%.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . Data through .
The 50 firms with the most events
How the figures were made
This table shows activity, not quality or safety, and it is not a recommendation.
The register has no sales figures. A maker or a firm with more products on the market can have more recalls.
An event is one recall that FDA reports under one event number. It can have many product records. The class is for the product of a recall. It is not a class of the firm.
Firms whose name reads as the name of a person are left out, as on the rest of the register.
A program makes this page from the agency files with fixed sentence rules. How the register is made. Data sources and licences.
In earlier editions
This table is in the edition of October 2026, the first edition. Each month adds an edition that keeps the first rows of the table as they were.
Other findings
Cite this page
Recall Register. Firms with the most FDA enforcement events. https://recallregister.com/findings/fda-firms-by-events/. Source: openFDA enforcement reports. Data through .