Drugs

2025 Medical Device Recalls Down, Drug Recalls Up

The Sedgwick Recall Index says there were 978 medical device recalls in 2025 involving 490.23 million units. The report says that was fewer recalls but more units than in 2024 (1,059 events and 440.41 million units). The total number of recalled units in 2025 was the highest level recorded in the past four years and the second highest in 20 years.

Device failure was the leading cause of 2025 recalls, with 141 events, the highest number attributed to this cause in 10 years. Software was the second-highest cause, and labeling was third.

The 136 Class 1 recalls set a record for 2025. There were 114 Class 1 recalls in 2024 and 85 in 2023. The number of affected units in Class 1 recalls was up 54.4% from 39.48 million in 2024 to 60.97 million units in 2025.

For drugs, there were 362 recalls in 2025 involving 99.73 million units. In 2024 there were 356 recalls involving 41.53 million units. There was a 140.2% increase in the number of units recalled year-over-year.

Failed specifications was the leading cause of drug recalls, with 76 events. CGMP was the second highest cause with 68 events, up from 33 in the previous year. At 49 recalls, sterility was the third highest cause.

In terms of units, contamination was the leading cause with 25.41 million units, a 10-year high for this cause. Subpotency was second, and mislabeling was third.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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