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Early Alert: Defibrillation Lead Issue from Boston Scientific
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Early Alert: Electrophysiology Catheter Issue from Medline ReNewal
Recall affects certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters
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Early Alert: WATCHMAN Access System Issue from Boston Scientific
Boston Scientific has issued a letter to affected customers recommending all lots of certain WATCHMAN Access Systems have updated use instructions
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FDA Names Top HHS Lawyer as Chief Counsel
FDA Names Top HHS Lawyer as Chief Counsel
http://www.fda.gov/news-events/press-announcements/fda-names-top-hhs-lawyer-chief-counsel
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FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use: Drug Safety Communication
FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use. Class-Wide Action Will Further Emphasize and Characterize Risks of Long-Term Use to Help Patients, Health Care Professionals Make Informed Treatment Decisions: Drug Safety Communication
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FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks
FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks
http://www.fda.gov/news-events/press-announcements/fda-requires-major-changes-opioid-pain-medication-labeling-emphasize-risks
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FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers
FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers
http://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers
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FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients
FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients
http://www.fda.gov/news-events/press-announcements/fda-recommends-removal-voluntary-hold-elevidys-ambulatory-patients
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FDA Investigating Death of 8-Year-Old Boy Who Received Elevidys
FDA Investigating Death of 8-Year-Old Boy Who Received Elevidys
http://www.fda.gov/news-events/press-announcements/fda-investigating-death-8-year-old-boy-who-received-elevidys
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Disposable Surgical Stapler Cartridge Correction: Ethicon Endo-Surgery, LLC Issues Correction for Endopath Echelon to Address Inadvertent Lockout During Surgical Procedures
Ethicon Endo-Surgery is correcting the Endopath Echelon due to a potential surgical lockout that stops cutting or stapling and requires extra removal steps.
