X-Frame-Options: SAMEORIGIN
: 516-482-9001

Tag Archives: Recalls

FDA Import Alert
25 Jun

Import Alerts for Certain Olympus Medical Devices

FDA Update – June 25, 2025 Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers We are seeing more and more regulatory actions against foreign companies because of lack of FDA QSR compliance. When a company has a violative inspection, and the FDA does not accept their corrective

16 Apr

Philips Respironics Recall

FDA update April 11, 2024 Federal District Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines A federal district court entered a consent decree against Philips Respironics (Philips). The consent decree includes key provisions aimed to prioritize patient relief and ensure the company’s regulatory compliance. The consent decree comes after

Archives