MedWatch Safety Alert
FDA
Early Alert: Transcatheter Mitral Valve Delivery System Issue from Edwards Lifesciences
Potential balloon burst during inflation can lead to embolism or the need for surgery.
From the U.S. Food & Drug Administration
Medical News
The latest FDA press releases, MedWatch safety alerts and medical device recalls, updated automatically every 30 minutes.
News provided by the U.S. Food & Drug Administration (fda.gov). MedFDAWatch is not affiliated with the FDA.
Last updated: 2026-10-15 22:08 UTC
Press Release
FDA
FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development
The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases.
Press Release
FDA
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
MedWatch Safety Alert
FDA
Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter
FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 13, 2026 – Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level. This recall is being conducted due to the presence of particulate matter, identified as cellulose, polystyrene, …
MedWatch Safety Alert
FDA
Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall
Avid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides.
MedWatch Safety Alert
FDA
Convenience Kit Recall: Medline Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall
Certain Medline convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination
MedWatch Safety Alert
FDA
Early Alert: Diagnostic Ultrasound System Issue from Philips Ultrasound
A software app or transducer connection problem with the Philips Lumify diagnostic ultrasound system can result in loss of or delays in scanning functionality.
MedWatch Safety Alert
FDA
Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter
FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 8, 2026 –Par Health is voluntarily recalling two lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) to the hospital level. The product is being recalled due to the presence of particulate matter identif…
Device Recall
FDA
Nova Biomedical® Announces Global Medical Device Correction for StatStrip® Glucose Hospital Meter
WALTHAM, Mass., October 5, 2026 – Nova Biomedical initiated a global Medical Device Correction on July 24, 2026, for the StatStrip® Glucose Hospital Meter System due to a software issue that may cause a glucose result to be associated with the wrong patient. When a patient ID bar…
Press Release
FDA
FDA Seeks Public Input to Support Ibogaine Research
The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches.
MedWatch Safety Alert
FDA
Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets
BD Alaris Pump Infusion Sets are being removed and discontinued; Alaris Pump Module model 8100 has updated performance data
MedWatch Safety Alert
FDA
IV Tubing Set Correction: ICU Medical Updates Use Instructions for IV Tubing Sets
Black specks and particulate reported in drip chambers of certain ICU Medical IV tubing sets does not affect device safety, performance, or intended use.
MedWatch Safety Alert
FDA
Breathing Circuit Recall: Draeger Removes VentStar Resus Neo Hoses
Removal of VentStar Resus Neo hoses due to the potential for cracks resulting in restricted ventilation or delayed therapy.
Press Release
FDA
FDA Approves First Heart Valve Designed to Grow with Children
The U.S. Food and Drug Administration today approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease.
MedWatch Safety Alert
FDA
Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels
IMMEDIATE RELEASE - Tomball, Texas – October 1, 2026 – Greenwich Rx, a 503A compounding pharmacy, is voluntarily recalling specific lots of its compounded glutathione to the consumer level. The product is being recalled due to potential elevated endotoxin levels.
Press Release
FDA
FDA Launches Nationwide Effort to Expand Scientific Expertise and Consumer Voices to Advisory Committees
The U.S. Food and Drug Administration today announced a broad, nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees— the independent bodies that inform some of the most consequential decisions in American public health.
Press Release
FDA
FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
The U.S. Attorney’s Office for the Middle District of Florida and the Criminal Division of the U.S. Department of Justice today announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals.
Press Release
FDA
FDA Approves First Treatment for MCT8 Deficiency
The U.S. Food and Drug Administration today approved Emcitate (tiratricol) tablets for oral suspension to treat peripheral thyrotoxicosis (excess thyroid hormone levels in the blood that causes symptoms, such as rapid heart rate, increased blood pressure and adverse effects on me…
Press Release
FDA
FDA intends to evaluate changes to the PMTA regulatory framework
FDA is carefully reviewing its experience implementing the Premarket Tobacco Product Application (PMTA) rule, as well as recent judicial developments, including a federal lawsuit filed in the U.S. District Court for the Northern District of Texas challenging the current regulator…
MedWatch Safety Alert
FDA
Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters
Boston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism
MedWatch Safety Alert
FDA
Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules
BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules
MedWatch Safety Alert
FDA
Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers
Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.
Press Release
FDA
Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions
A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal le…
MedWatch Safety Alert
FDA
Early Alert: Heart Pump Controller Issue from Abiomed
Abiomed is removing certain Impella Controllers with various hardware, firmware, and/or software updates based on a retrospective review of servicing records.
MedWatch Safety Alert
FDA
Early Alert: Ventilator Issue from React Health
IFT cable connector on VOCSN devices may become unseated and lose communication with internal flow transducer board leading to reboots, System Fault 10 Alarms.
Press Release
FDA
FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing
The FDA today issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use before they’re tried in humans.
MedWatch Safety Alert
FDA
Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter
ROCHESTER, MI– September 18, 2026 –Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulos…
MedWatch Safety Alert
FDA
Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride Ampules
AVID Medical is correcting convenience kits containing recalled Huons Co. sodium chloride ampules.
MedWatch Safety Alert
FDA
Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection
Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain …
MedWatch Safety Alert
FDA
Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets
The cannula sets may exhibit a loose connection between the flexible tubing and the nasal cannula resulting in reduced effectiveness and decreased oxygenation.
MedWatch Safety Alert
FDA
Nitric Oxide Delivery System Correction: NOxBOX Updates Use Instructions for NOxBOXi Nitric Oxide Delivery System
The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
MedWatch Safety Alert
FDA
Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules
Spectra Medical Devices is removing Sodium Chloride Flush products that were manufactured by Huons Co,. Ltd.
Press Release
FDA
FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A.
Press Release
FDA
FDA Launches Expedited IND Pilot, Begins Accepting Applications
The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot.
MedWatch Safety Alert
FDA
Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device
The Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule can fail to attach to the esophagus or detach from its delivery device.
Press Release
FDA
FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter paren…
Press Release
FDA
FDA Grants Accelerated Approval to a New Breast Cancer Treatment
The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them.
Press Release
FDA
FDA Approves First Drug to Treat Alexander Disease
The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients.
Press Release
FDA
FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats
The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar
Press Release
FDA
FDA Seeks Public Input to Advance Development of Botanical Drug Products
The U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.
Press Release
FDA
FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder
The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells.
Press Release
FDA
FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults
The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults.
Press Release
FDA
FDA Issues Emergency Use Authorization for Generic Drug to Prevent New World Screwworm in Cattle
FDA issues Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the prevention of New World screwworm (NWS) infestations (myiasis) in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound.
Press Release
FDA
FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer
The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule.
Press Release
FDA
FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes.