Class I Recalls Hit 15-Year High, According To Index Report From Sedgwick

Medical device recalls exceeded 1,000 in 2024, according to a recently published recall index report from Sedgwick. More than 10% of those recalls were class I, the FDA’s most serious category.

There were more than 3,200 product recalls in the US last year, matching last year’s total and representing the second-highest total in the past six years, according to a report from global claims management firm Sedgwick.

More from Medtech Insight

Research Finds Benefit From DME Suppliers For People Living With Diabetes

 
• By 

People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.

EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025

 

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.

Owlstone Medical Develops P.aeruginosa Breath Test For Cystic Fibrosis Patients

 

Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.

US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group

The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.

More from Policy & Regulation