FDA Device Recall Records Jump 28% in 2026, But Distinct Events Show Modest Increase

While the number of FDA device recall records saw a 28% increase in 2026, the actual number of distinct recall events rose by only 2.5%. Furthermore, Class I events, which are the most serious type of recall, decreased by 16%. This discrepancy is largely attributed to how kitted products are counted and specific actions by two firms, Medline and Olympus.