FDA Facing Increased Scrutiny Over Medical Device Recalls

In 2022, nearly 900 medical devices were recalled by FDA, representing a 125% increase compared to 2012, which saw 399 recalls. That number included 70 Class I recalls — FDA’s highest and most serious classification — becoming a 15-year high. Medical device adverse event (AE) reports also increased by 505% from 2012 to 2022.