Weekly Vitals: Stryker Expands Recall, EU to Revamp Medical Device Rules

In this week's medical device manufacturing news, Stryker announced that it has expanded the recall of waste management systems because FDA has not given it 510(k) clearance. On the legal front, Revolutions Medical said that is has filed suit against former consultants, alleging that the defendants misled and misrepresented capabilities and progress related to the development and manufacture of the company's autoretractable vacuum safety syringe. Meanwhile, after weak European Union regulations were partly blamed for a scandal over French-made breast implants, the EU says that it wants to establish tougher rules governing the safety and monitoring of medical devices.