Healthcare news
Breaking news, regulatory updates, FDA / EMA / WHO / national health ministry announcements.
- FDA
Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
Affected grafts may not unclasp from the delivery system. This may require conversion to open surgical repair and can result in patient death.
- FDA
Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems
Trividia recommends that device users who receive an E-5 error code and are experiencing symptoms of high glucose should seek medical care immediately.
- FDA
Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication
FDA alerts of risks with use TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health.
- FDA
Early Alert: Anesthesia Machine Issue from Draeger, Inc.
Draeger is correcting additional anesthesia workstations due to a manufacturing error that may cause the ventilator to fail before or during use.
- FDA
Sun Pharmaceutical Industries, Inc. (Sun Pharma) Initiates Voluntary U.S. Nationwide Recall of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Due To Potential Presence of Glass Particles
FOR IMMEDIATE RELEASE MUMBAI, INDIA and PRINCETON, NJ - May 13, 2026 – Sun Pharma is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials). The single batch of 675 vials i
- FDA
FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA
FDA continues to implement its bold food agenda, with two decisive actions focused on food chemical safety.
- FDA
Convenience Kit Recall: AVID Medical Removes Convenience Kits Containing Namic RA Syringes
The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.
- FDA
Pharmacal Issues Nationwide Recall of MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream Due to Microbial Contamination
- May/8/2026- Jackson, WI, Pharmacal is recalling one lot of MG217 Multi-symptom Treatment Cream Skin Protectant Eczema Cream, 6oz tube to the consumer level. The product has been found to be contaminated with Staphylococcus aureus.
- FDA
FDA Advances Drug Repurposing to Address Unmet Medical Needs
FDA announced it is soliciting input on efforts with respect to drug repurposing to help address unmet medical needs across a range of diseases and conditions.
- FDA
Convenience Kit Recall: Aligned Medical Solutions Removes Convenience Kits Containing Namic RA Syringes
The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.
- FDA
FDA Grants Seventh Approval under the National Priority Voucher Pilot Program
FDA issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts.
- FDA
FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics
The U.S. Food and Drug Administration today issued a final guidance for industry, Postapproval Pregnancy Safety Studies, with recommendations on different methodologies that can be used in the postapproval setting to study the safety of drugs and biological products when used during pregnancy.
- FDA
Convenience Kit Recall: American Contract Systems Removes Convenience Kits Containing Namic RA Syringes
The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.
- FDA
Convenience Kit Recall: Medical Action Industries Removes Convenience Kits Containing Namic RA Syringes
The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.
- FDA
Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps
Brady SMR6 is now available for ACCOLADE pacemakers and CRT-Ps; correction expanded to include CRT-P and DR-EL devices.
- FDA
Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication
Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.
- FDA
FDA Expands AI Capabilities and Completes Data Platform Consolidation
FDA announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.
- FDA
FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
FDA announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient.
- FDA
Disruptions in Availability of Neurosurgical Patties, Sponges, and Strips - Letter to Health Care Providers
The FDA issued a LHCP to notify providers that Neurosurgical Patties, Sponges, and Strips (product code HBA) are experiencing a supply disruption.
- FDA
FDA Expands Market Access, Authorizes New ENDS Products
FDA today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway.
- FDA
Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads
Certain SureForm Surgical Stapler reloads may form incomplete staple lines, leading to severe bleeding or death.
- FDA
Sizing Catheter Recall: Cook Medical Removes Various Centimeter Sizing Catheters
When the sizing catheters are used during angiographic procedures the marker bands may be at an increased risk of cracking/breakage.
- FDA
Trividia Health Correction for TRUE METRIX Blood Glucose Monitoring Systems
FT. LAUDERDALE, FL – May 1, 2026 – Trividia Health, Inc., a global leader in diabetes management, today provided an important update to the medical device labeling correction it announced on February 6, 2026, for all TRUE METRIX®, TRUE METRIX® AIR, TRUE METRIX® GO, and TRUE METRIX® PRO Blood Glucose
- FDA
FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
FDA is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib.
- FDA
FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia
The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults.