Section
FDA guidance, QMSR and ISO 13485, EU MDR, standards revisions (ISO 11607, 11135, 11137, 10993, ASTM), audit findings, UDI.
FDA entered termination dates on 288 recall records (72 recall events) in 2025, against 1,607 recall records (527 recall events) in 2024. Of recall records initiated in the first half of 2023, 2.6% were terminated within three years, against 89% of those initiated in 2016.
The RES endpoint reaches back to late 2002. The enforcement endpoint, the only one carrying Class I, II and III, holds 0 records dated before 2012-06-20, so 7,527 of the 22,500 recall events in RES (33.45%) have no severity in the API.
FDA's recall record carries the firm's own answer to why. In every year since 2021, more recalls name the process that built the device than name the device's design. On close to a quarter of 2025's recalls the firm had named nothing at all.
FDA guidance, QMSR and ISO 13485, EU MDR, standards revisions (ISO 11607, 11135, 11137, 10993, ASTM), audit findings, UDI.
Every factual claim links to a primary source, standards are cited by number and year, and sponsored and contributed pieces carry a label. That is the whole method, and it is written out on the ethics policy.
This section has its own feed at /regulatory/feed. The FDA data on this site does not wait for the newsroom: clearances, recalls, product codes and company records are live at the data hub.
