Class I Recall For Integra’s CereLink Intracranial Pressure Monitors

The US FDA has labelled a June recall of intracranial pressure monitors from Integra with its most serious designation, class I.

Recall
• Source: Shutterstock

In June, Integra LifeSciences initiated a recall of 388 CereLink intracranial pressure monitors (ICPs) because of reports that readings from the devices were inaccurate. The company also adjusted its quarterly and yearly earnings to reflect the impact of the recall. (Also see "Integra Issues Recall Of Intracranial Pressure Monitors" - Medtech Insight, 25 August, 2022.)

The Food and Drug Administration has now labelled that recall as class I.

More from Regulation

More from Policy & Regulation

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 

Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.

Global Medtech Guidance Tracker: May 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.