Drugs
The Sedgwick Recall Index covering the first half of 2026 shows that the number of medical device recalls fell from 487 to 462 (down 5.1%), while the number of units recalled increased 516.8% from 50.7 million units in the first half of 2025 to 313.07 million
Devices
FDA has cleared Roche/Eli Lilly’s Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test as a single blood-based option to aid in identifying amyloid pathology associated with Alzheimer's disease in individuals 55 years and older with signs, symptoms, or complaints of cognitive decline. The companies say
Devices
FDA has issued an early alert about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal continuous positive airway pressure (CPAP) sets that may develop a loose connection between the tubing and nasal cannula. Earlier this month, the company sent affected customers a letter recommending that
Devices
CDRH is issuing an Early Alert after becoming aware that GE HealthCare issued a letter alerting affected customers of updated use instructions for Portrait Mobile Monitoring Solutions devices operating on certain version of Portrait Core Services software. The alert recommends that users ensure “appropriate alternative monitoring is established for patients
Devices
Boston Scientific has recalled its ENROUTE Transcarotid Neuroprotection System Plus, a single-use percutaneous catheter kit used during transcarotid artery revascularization. The device is intended to provide direct carotid access and dynamic blood flow reversal to capture loose plaque debris, protecting the brain from strokes during carotid stenting. An FDA
Devices
Medline has issued a device correction (Class 1 recall) for convenience kits containing B. Braun’s bupivacaine hydrochloride components. An FDA notice says Medline issued a letter to affected customers recommending that certain Medline convenience kits be corrected prior to continued use by removing components affected by the B. Braun
Devices
FDA Digital Health Center of Excellence director Rick Abramson says that digital health technologies (DHTs), especially those enabled by artificial intelligence, can continuously capture information about a person’s health in real time and in the context of their everyday life. Writing in an FDA Voices column, Abramson says DHTs
Devices
FDA has granted Vitestro a de novo authorization for Aletta, the first standalone robotic device designed to draw blood from a patient’s arm without hands-on intervention by a phlebotomist. The device is authorized for use in adults in outpatient settings and must operate under the supervision of a
Devices
A systematic analysis conducted by university researchers around the world of all FDA-cleared artificial intelligence/machine learning-enabled medical devices through 12/5/2025 highlights a “profound validation gap” and the need for evidence standards capable of keeping pace with the speed of regulatory clearance. Writing in the open-
Devices
Mosaic Clinical Technologies is petitioning FDA to clarify the regulatory status of commercially available artificial intelligence vision language models (VLMs). The petition says VLMs perform medical image analysis to support diagnosis and treatment and ensure consistent application of medical device requirements to these tools. “The safety and effectiveness of these
Devices
FDA is soliciting stakeholder feedback on a discussion paper outlining considerations for regulating AI-enabled medical devices. The paper says generative artificial intelligence (GenAI)-enabled medical devices “hold transformative promise for patient care and the broader health ecosystem.” It also says such devices may introduce unique risks when compared to
Devices
Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may allow air bubbles to enter the administration set during pressure infusion or flushing, potentially exposing patients to serious injury or death. The issue involves the potential formation of air bubbles in the drip
Devices
On behalf of FDA, the Justice Department has asked the Nevada federal court to issue an injunction to stop Steiner Biotechnology from manufacturing and selling adulterated and misbranded dental products. A department media statement says FDA inspected the Steiner manufacturing facility at least four times from 2018 to 2025, finding
Devices
An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators be removed from where they are used or sold. Hamilton Medical says that certain lots of coaxial breathing circuit sets preassembled with
Devices
FDA is announcing a 9/23 meeting of its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to vote on a Grail PMA for the Galleri test. The test is described as a prescription-only qualitative, next-generation sequencing-based in vitro diagnostic test intended to detect
Devices
AdvaMed says it strongly supports the draft MDUFA 6 agreement. Speaking at an FDA public hearing, association executive vice president for digital and diagnostics technologies Zach Rothstein said the commitment “builds on what is working, makes practical improvements where they are needed, and prepares the program for the technologies FDA
Devices
The International Medical Device Regulators Forum (IMDRF), of which FDA is a founding member, has published a final document outlining global principles for Predetermined Change Control Plans (PCCPs), a regulatory approach intended to streamline updates to medical device software while maintaining safety and regulatory oversight. The “Essential Principles and Content
Devices
FDA has issued an early alert warning healthcare providers not to use certain Becton Dickinson (BD) intraosseous vascular access needle sets after the company identified a manufacturing defect that has been linked to delays in establishing emergency vascular access, including reports of four deaths and 45 serious injuries. The alert
Devices
A 2/2-2/6 FDA inspection at Koven Technologies in St. Louis, MO, found Quality Management System Regulation (QSMR) violations in the firm’s production and/or marketing of the Bidop 3 Doppler. A just-released 7/21 Warning Letter lists these violations: * failure to document procedures to control
Devices
FDA has issued an updated final guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices,” which describes current recommendations for applying human factors and usability engineering during the design and development of medical devices, revising a 2016 document to reflect changes in quality system requirements and current regulatory
Devices
Resmed has recalled (Class 1) its Astral 100/150 ventilator system due to the potential for a supercapacitor electrolyte leakage on the printed circuit board assembly that may damage the charger chip, causing a fail-safe state and interruption of ventilation therapy. An FDA notice says the agency determined the
Devices
FDA has granted de novo authorization for Caristo Diagnostics’ CaRi-Heart, described by the company as the first and only technology authorized in the U.S. to quantify coronary inflammation from routine coronary CT angiography. A company statement says it will begin the CaRi-Heart commercial launch this quarter and