Fda alerts app recalls. Mar 20, 2025 · Stay Safe with USA Recalls – Real-Time Alerts Recalls of Food, Drugs, and More Every year, thousands of products are recalled due to contamination, undeclared allergens, and safety risks. Set to launch next week with watchOS 26, this feature will enable select Apple Watch models to alert users to potential signs of chronic high blood pressure. It’s by SmartAddress, Inc. Food and Drug Administration (FDA) are listed in the widget. See screenshots, ratings and reviews, user tips, and more games like Food Recalls &… Sep 12, 2025 · Apple Watch Hypertension Alerts Gain FDA Approval for 2025 Rollout Apple has taken a significant step in advancing wearable health technology with its newly FDA-cleared hypertension detection feature for the Apple Watch. 5 released an alert notifying patients of a safety concern using diabetes devices such as continuous glucose monitors, insulin pumps and automated insulin dosing systems that rely on a smartphone for delivering alerts. It detects possible convulsive seizures and instantly alerts caregivers, whether they're sleeping next door or are living miles away. Jan 31, 2025 · The FDA posts information about certain medical device recalls and early alerts to help increase awareness of these issues. Never worry about missing an FDA recall or a safety notification again. 7 of the mobile app. Use this page for the latest on signing up for Toxic Drug and Public Health Alerts, as well as accessing overdose prevention, drug checking and substance use services in BC. It is important that consumers be aware of recalls because recalled Dec 8, 2024 · Tandem Diabetes Care, Inc. In a new FDA alert, the agency is warning diabetes patients who use devices such as smartphones, continuous EpiWatch® is the first and only FDA-cleared seizure detection app for Apple Watch. Nov 18, 2025 · US | FDA | USDA | Outbreaks | Pet Food Food-borne illnesses can be devastating worldwide. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the Oct 23, 2025 · Drug Shortage Notifications For Industry Industry can notify FDA Drug Shortage Staff of drug and supply shortages via the CDER Direct NextGen Portal. Sep 29, 2022 · Software functions (typically mobile apps) that transform a mobile platform into a regulated medical device and therefore are the focus of the FDA's regulatory oversight: These mobile apps use a Aug 28, 2024 · The recalled t:connect mobile app is an Apple iOS-based software and is for Version 2. Now you can easily get information on unsafe foods, deadly outbreaks & recall alerts right on your phone so you and your love… Feb 15, 2024 · Here’s how!You can try this free app called Food Recalls & Alerts. com’s Drug Interaction Checker, trusted by doctors and patients, to instantly review your meds for unsafe combinations. Connecting new hardware to the smartphone, such as connecting to car audio or using wireless Stay Ahead of Food, Pet Food & Drug Recalls with Recall Radar! Every year, millions of pounds of food and thousands of pet food & drug products are recalled due to contamination, allergens, and safety risks. USA Recalls keeps you and your loved ones safe by providing inst… May 24, 2022 · The free Food Recalls & Alerts phone app (Apple and Android) will allow you to get recall notifications all in one place on your phone. Main FDA Warning Letter PageLearn about the types of warning letters on FDA's website. Stay on top of food recalls and alerts in the US. health officials warned. Nov 19, 2025 · Information For Alerts and People Who Use Substances This page contains important information about staying safe. In the US alone, over 48 million people get sick, 128,000 are hospitalized, and 3,000 die from contaminated food products each year. Oct 21, 2024 · Report an emergency If you are experiencing a life-threatening medical emergency, call 9-1-1. Users of these smartphone -compatible diabetes devices can configure alert settings, such as which alerts to receive, how often and how the alerts are delivered through the app Feb 6, 2025 · The FDA has identified, among others, the following hardware and software changes, updates and configurations that may lead to critical alerts not being received as expected: software configuration issues, such as app notification permissions, using "do not disturb" or "focus mode" or the app entering "deep sleep" after a period of not being used; connecting new hardware to the smartphone FDA Alert This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network. Department of Agriculture (USDA) and U. Includes FDA, USDA and pet food recalls. Feb 6, 2025 · The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood glucose level alerts from diabetes-related smartphone devices due to The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States Key Features • My Drug List – Add your medications to instantly assemble relevant medical information in a simple, easy to read personalized format. Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online. Created to offer round-the-clock safety and comfort, to help people with epilepsy get help when they need it most. Every query to the API must go through one endpoint for one kind of data. Our app offers a comprehensive suite of features designed to keep you informed and protected from potential risks. gov -- a "one stop shop" for U. Each of these nouns has one or more categories, which serve unique data-such as data about recall enforcement reports, or about adverse events. Sep 25, 2025 · This import alert does not apply to GLP-1 API from manufacturers that, based on an FDA inspection or other FDA evaluation, appear to be in compliance with FDA’s rigorous standards for Feb 8, 2025 · The FDA is also working with manufacturers to ensure that settings in smartphones and mobile medical apps that may impact safety alerts are continuously tested, and any updates to recommended configurations are communicated quickly and clearly to users. Live more independently with confidence on your wrist. Some users may miss important notifications from their diabetes management apps due to software settings, hardware changes (such as connecting Jul 12, 2024 · FDA drug alerts in psychiatry, including drug approvals, drug warnings, FDA medical device recalls, and FDA drug label updates for 2024. The clearance process for medical devices involves an extensive and independent review of the clinical data showing that a device is safe and effective, as well as an assessment of testing related to usability and cybersecurity. Government recalls. Smart notifications, AI-powered product scanning, and automatic monitoring to protect your family. Feb 28, 2025 · FDA drug alerts in endocrinology, including drug approvals, drug warnings, FDA medical device recalls, and FDA drug label updates for 2025. Embrace2 is the world's first FDA-cleared wrist-worn wearable in epilepsy. Download Food Recalls & Alerts by SmartAddress, Inc. 5, 2025 /PRNewswire/ -- Today, the U. accessdata. Sep 5, 2024 · This recall involves removing certain devices from where they are used or sold, and does not apply to the FreeStyle Libre 3 reader or app. You can choose just Millions of Americans are impacted by thousands of food recalls every year. Now you can easily get information on unsafe foods, deadly outbreaks & recall alerts right on your phone so you and your loved ones (including your pets) can stay safe from Mar 3, 2025 · Key takeaways: The FDA has issued a warning to users of continuous glucose monitors after reports of missed urgent blood sugar alarms on smartphones. Food recalls, safety alerts and advisories, outbreak investigations, and keeping food safe in emergencies. gov WARNING: This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes all devices/storage media attached to this system. - Health Professionals - Tailored tools and information for medical professionals, including FDA monographs. Apps for diabetes devices allow users to configure alert settings, such as which alerts to receive, how often, and how the Feb 11, 2025 · Last week, the U. Oct 17, 2024 · On July 31, 2024, Medtronic sent all affected customers a Safety Alert stating that users should follow their pump’s built in alerts and alarms battery status for the MiniMed 600 series and 700 The Food and Drug Administration on Thursday cleared a new hypertension detection tool for the Apple Watch. Sep 15, 2025 · Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of hypo/hyperglycemia. ) It includes FDA, USDA and pet food recalls. Recall Radar keeps you informed with real-time alerts and recall tracking. MedWatch RSS FeedFrequently Asked Questions: RSS What Is RSS? RSS stands for R eally S imple S yndication. Feb 12, 2025 · The FDA warns that some users of CGMs and insulin pumps connected to smartphones miss important blood sugar alerts due to phone issues. www. The FDA has pinpointed a few issues behind the missing alerts: Software configuration issues, such as app notification permissions, using "do not disturb" or "focus mode," or the app entering The FDA is alerting patients of a safety concern regarding diabetes devices that rely on a smartphone to deliver critical safety alerts. Feb 6, 2025 · FDA warns of missed alerts in smartphone-compatible diabetes devices February 6, 2025 On February 5, FDA issued a safety alert regarding smartphone-compatible diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing systems. Recall Pal is your ultimate product recall and safety alert tracker. The agency has received reports that patients are not receiving or hearing the alerts even though they thought the alerts had been configured for delivery. Key Features:… Oct 22, 2025 · Safety reporting portal for health professionals, patients, consumers and industry. S. Seizure alerts include the time and last known location for the individual experiencing seizure activity. Feb 27, 2025 · Google on Tuesday received clearance from the U. Make health tracking seamless and stylish with these reliable and cutting-edge options. Feb 5, 2025 · Provided by PR NewswireFeb 5, 2025 4:46pm FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices Feb 5, 2025 · The FDA’s warning focused on three primary factors that can cause patients to miss out on urgent health alerts: Software configuration issues, such as app notification permissions, using “do not disturb” or “focus mode” or the app entering “deep sleep” after a period of not being used. These notices may include a list of possible medication recalls, market withdrawals, alerts and warnings. Tonic-clonic seizures, or grand mal FDA is working with federal, state, and local officials, and with Canadian public health authorities regarding a norovirus outbreak linked to raw oysters from British Columbia, Canada. Learn about missed alerts, safety recommendations, and how to pro Feb 5, 2025 · The FDA today issued an alert around a safety concern regarding diabetes devices that rely on smartphones to deliver critical safety alerts. The FDA is working with diabetes-related medical device manufacturers to ensure that smartphone alert configurations of their devices are carefully evaluated before use by patients. Aug 18, 2023 · Explore our top picks for the best smartwatches with ECG that have FDA approval. Seizure alerts are sent to the caregiver contacts set up on the user’s app, and are delivered via phone, text or email. You can request real-time push alerts to your phone, or just check the app recall list as often as you’d like if you don’t like notifications. Report any diabetes device issues to the FDA. Get Medisafe (Free) Apple App Store Google Play Web Portal Login Features Medication Management Family Tracking Measurement Trackers Drug Interactions Refill Reminders Appointment Reminders Condition Resources Community Compare Adherence Become an Ambassador Join Beta Group See Reviews More on Medisafe Feb 7, 2025 · The Food and Drug Administration Feb. Apr 3, 2021 · If you often forget to take your meds on time or track your health, you should immediately install the best ten medication tracker and pill reminder apps. EpiWatch is an app running on Apple Watch that detects, alerts and monitors for tonic–clonic seizures. Your Trusted Source for Product Recalls Get real-time updates about food, drug, and medical device recalls so you know the facts and how to respond. Permissions We request limited permissions to improve your experience: - Network access: Required to connect to our database. (Nasdaq: TNDM) today provided an update on the March 2024 recall of its Apple iOS t:connect mobile app in the United States relating to an issue that can cause rapid Sep 15, 2025 · The FDA identified a recall of smartphone apps for Dexcom (Nasdaq:DXCM) continuous glucose monitors as the most serious type. The FDA is sounding the alarm after receiving multiple reports of users missing or not hearing Feb 5, 2025 · The FDA is warning diabetes patients that information from CGMs, insulin pumps, and automated dosing systems could fail to be delivered if smartphone settings are not properly configured. In other cases, connecting the phone to a new audio source, such as a car stereo, could change the volume of the alerts users are accustomed to Feb 6, 2025 · If alerts are missing or inaudible, contact your device’s technical support. - FDA Alerts - Stay up to date with product recalls, safety alerts, and FDA-related news. , Feb. The t:connect mobile app works with the t:slim X2 insulin pump with Control-IQ technology. But the FDA warns that certain phone settings, such as pausing notifications, may cause patients to miss critical updates. Feb 5, 2025 · These days, many devices are programmed through apps on patients’ phones. Feb 25, 2025 · On February 5 th, 2025, the FDA posted an alert to patients about a safety concern regarding diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing systems, that rely on a smartphone to deliver critical safety alerts. This portal is intended ONLY for drug The proliferation of mobile apps in healthcare has prompted the FDA to clarify its enforcement priorities. But the FDA warns that certain phone settings, such as pausing notifications, may cause patients to miss critical Feb 12, 2025 · The FDA notice concerns continuous glucose monitors, insulin pumps, and automated insulin dosing systems that rely on a smartphone to deliver critical safety alerts. Drug information including database apps, email alerts, podcasts, news feeds, meetings and conferences, webinars, videos Search 24,000+ prescription, OTC, and natural medications. Aug 24, 2025 · - FDA Alerts: Stay up to date with product recalls, safety alerts, and FDA-related news. This system is provided Apr 22, 2025 · Introducing FDA Recall Alert, your go-to solution for ensuring the safety of your pantry at home and inventory for your business. Is your medical app in an affected category? Stay Safe with USA Recalls – Real-Time Alerts Recalls of Food, Drugs, and More Every year, thousands of products are recalled due to contamination, undeclared allergens, and safety risks. Dec 27, 2024 · FDA experts report changes in drug approvals, warnings, and indications for products for use by dermatologists and aesthetic medicine professionals. May 16, 2025 · Information for FDA personnel, import brokers, wholesalers, retailers and consumers about import products. Jan 13, 2025 · Info related to recall of medical devices, corrections and removals; regulations and Federal Register notices. — Here's a health alert for those who use smartphone apps to manage their diabetes. Why This Matters Your diabetes device sends alerts to warn you about low or high blood sugar. Indications for use Your Family's Safety Guardian Real-time product recall alerts from CPSC, FDA, USDA and more. Peer-reviewed, clinically sourced drug information for safer, smarter health decisions. on the App Store. (See image below. Detect tonic-clonic seizures, send real-time alerts to caregivers, and reduce the risk of SUDEP. About the openFDA API openFDA is an Elasticsearch-based API that serves public FDA data about nouns like drugs, devices, and foods. Feb 6, 2025 · The FDA issued an alert to patients of potential safety concerns for diabetes devices, including continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing systems, specifically those that rely on a smartphone to deliver safety alerts. The FDA has identified this recall as the most serious Sep 13, 2017 · You'll always be in the know with the new feature on the USDA's FoodKeeper food safety app, which sends alerts for new food recalls. The health feature was one of the highlights at Apple's September iPhone event and will Why is FDA clearance important? Empatica is proud to have received FDA-clearance for EpiMonitor. Read more here. If you don’t hear or receive these alerts, it could lead to serious health risks like: Severe hypoglycemia (low blood sugar) Severe hyperglycemia (high blood sugar Aug 24, 2025 · - FDA Alerts: Stay up to date with product recalls, safety alerts, and FDA-related news. To report an emergency involving food, drugs, medical devices, dietary supplements, or cosmetics, call Contact the FDA Import Programpage for information on Detention without Physical Examination (DWPE), import alerts, removal from import alert, or modifications to a firm/product listing on import Policy for Device Software Functions and Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff Document issued on September 28, 2022. Nov 21, 2025 · The following FDA safety notices may be specifically about Adzynma or relate to a group or class of drugs which include Adzynma. These devices rely on smartphones to deliver critical safety alerts, but users may miss these alerts due to hardware and Feb 5, 2025 · Patients who use smartphone apps to manage their diabetes could face serious health problems if they miss notifications needed to control their blood sugar, U. The FDA oversees the safety and effectiveness of a small subset of device software functions, including mobile medical applications. This system is provided Feb 5, 2025 · These days, many devices are programmed through apps on patients’ phones. Free apps can act as a backup for CGM alerts on your phone. We are committed to empowering you, the consumer, with real-time updates and comprehensive information about food recalls, car recalls, drug recalls, and much more. The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. It's an easy way for you to keep up with new safety information that's important to you Feb 5, 2025 · Missed Alerts Can Be Caused by Hardware and Software Changes, Updates and Configurations SILVER SPRING, Md. Food and Drug Administration (FDA) issued a safety alert for patients using diabetes devices, including continuous glucose monitors (CGMs), to ensure the settings in their phones were configured correctly to deliver critical alerts. Yet most people never hear about them in time. Nov 10, 2025 · The following FDA safety notices may be specifically about Mimvey Lo or relate to a group or class of drugs which include Mimvey Lo. The agency received reports in which users said the safety alerts are not being delivered or heard, even in cases where the user thought Apr 18, 2025 · The FDA warns about potential risks with smartphone-compatible diabetes management apps. Nov 10, 2025 · Get the latest up-to-date information on FDA drug recalls, withdrawals, and warnings. . Food and Drug Administration for the Pixel Watch 3's Loss of Pulse Detection feature, which can alert emergency medical services when the user's To provide better service in alerting the American people to unsafe, hazardous or defective products, six federal agencies with vastly different jurisdictions have joined together to create www. To search archived content, visit Search FDA Archive and input the name of Recalls, Market Withdrawals, & Safety Alerts Alerting you to the latest recalls of potentially unsafe FDA-regulated products gathered from press releases and other public notices. Food-borne illnesses can be devastating. Alerts Sign in Alerts Alerts Monitor the web for interesting new content How often As-it-happens Mar 19, 2025 · EpiWatch, the Apple Watch-based epilepsy management company spun out from Johns Hopkins, announced it received FDA 510(k) clearance for its continuous seizure monitor platform that utilizes the popular wearable to detect and alert for tonic-clonic seizures. A secondary alert system, like a CGM receiver or the SugarPixel standalone display, can ensure critical alerts are noticed. Jul 17, 2025 · Find a Recent Recall Real-time notices of recalls and public health alerts from the U. fda. Unauthorized or improper use of this system is prohibited and may result in Subscribe to MedWatch Safety Alerts Medical product safety information delivered to you via e-mail, Twitter, or RSS Nov 5, 2025 · Use Drugs. Follow the tabs above to obtain the latest recall information, to report a dangerous product, or to learn important safety tips. Food and Drug Administration is alerting patients of a safety concern regarding diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps and automated insulin Feb 6, 2025 · The FDA issued a warning regarding the safety of diabetes devices, such as continuous glucose monitors, insulin pumps, and automated insulin dosing systems, that rely on a smartphone to deliver critical safety alerts. Subscribe to alerts by email, app notification, or news feeds. Food and Drug Administration is alerting Feb 5, 2025 · Today, the U. To find a specific recall, you can scroll through the items listed in the widget and click on the recall or alert for more information. Access in-depth consumer information, FDA alerts, drug interactions, plus food, allergy and medical condition interactions. FDA Alert This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network. It collects all of the FDA, USDA and pet food recalls and will send real-time alerts about new ones to your phone. Unlike consumer devices offering seizure detection apps, EpiMonitor Feb 12, 2025 · The FDA has issued a safety communication regarding the potential for missed alerts with diabetes devices due to software or hardware changes. Feb 5, 2025 · The FDA is alerting users of diabetes-related medical devices that smartphones connected to diabetes devices may fail to send critical safety alerts. C. Feb 13, 2025 · CHARLOTTE, N. USA Recalls keeps you and your loved ones safe by providing inst… Nov 21, 2025 · The following FDA safety notices may be specifically about apadamtase alfa, recombinant or relate to a group or class of drugs which include apadamtase alfa, recombinant. - Health Professionals: Tailored tools and information for medical professionals, including FDA monographs. An invaluable tool for medication management and adherence. Apr 8, 2025 · EpiWatch — a Johns Hopkins Medicine spinout — has received FDA 510(k) premarket clearance for its seizure detection platform that runs on the Apple Watch. This system is provided for Government-authorized use only. gjdclg iqsjhzv adprzr osxhud yrpt gmxam fjsxfm csbn ahd bbbrp pwmbet kdmvji lhfpy qicgfe uel