Drugs

2024 Device Recalls Up, Drug Recalls Down: Sedgwick

The Sedgwick “State of the Nation 2025” report shows that medical device recalls increased 8.6% in 2024, from 975 recalls in 2023 to 1,059 in 2024. The report finds that drug recalls dropped 31%, from 571 in 2023 to 356 in 2024.

Device failure was the leading recall cause in 2024, accounting for 118 recalls (11%). Sedgwick says this was the highest failure rate in more than five years and the first time it has been the leading cause.

The total affected units surged 55.4%, from 283.4 million in 2023 to 440.4 million last year. With that increase, the report says, affected units are at their highest rate in three years.

Class 1 medical device recalls reached their highest level in 15 years, Sedgwick says.

On the pharmaceutical side, the company says failed specifications was the leading cause of 2024 drug recalls, accounting for 96 recalls, followed by current good manufacturing practice issues. The failed specifications statistic was the highest number of recalls attributed to this cause in over five years, it says.

Total affected units have now recorded two consecutive years of significant decline, according to the report.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome