Drugs

Device, Drug Recalls Down, Units Up

The Sedgwick Recall Index covering the first half of 2026 shows that the number of medical device recalls fell from 487 to 462 (down 5.1%), while the number of units recalled increased 516.8% from 50.7 million units in the first half of 2025 to 313.07 million units in the first half of this year.

Device failure was the leading cause of recalls with 66 events, down from 80 in the comparable period of 2025. Software issues were the second leading cause (54 events, down from 75), and mislabeling was the third leading cause (49, level with the 48 events in 2025).

For drugs, there were 177 recalls in the first half of 2026, down from 184 in the comparable period in 2025. However, the number of recalled units climbed 914% from 46.51 million units to 471.64 million.

The leading cause of drug recalls was failed specifications (45 events, up from 36), followed by sterility (34 events) and CGMP deviations (15 events). The 14 Class 1 drug recalls were a five-year low. Class 2 recalls also fell.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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