Fda alerts medical devices. Changes are bracketed by asterisks (***).

Fda alerts medical devices But problems also may arise when users--either health professionals or the general public--do not understand or follow proper use instructions. Mar 5, 2025 · This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The affected devices include specific models of ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors. time), the U. 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. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Jun 30, 2025 · Last week, the FDA notified healthcare providers about import alerts for certain medical devices manufactured in Japan by Olympus and its subsidiaries. Feb 5, 2025 · The FDA is working with diabetes-related medical device manufacturers to ensure that smartphone alert configurations of their devices are carefully evaluated prior to use by patients. Oct 22, 2025 · MedWatch alerts provide timely, actionable safety information on human drugs, medical devices, biologics, dietary supplements, and cosmetics. until further notice. 1 The Food and Drug Administration (FDA) and other standards organizations distinguish between alarms and alerts for medical devices by stating that alarms should be used when the operator’s HHS U. This regulatory intervention follows a prolonged period of non-compliance with the FDA Apr 18, 2025 · On April 7, 2025, the U. List of Medical Device recalls in 2022. Jun 25, 2025 · The United States Food and Drug Administration (FDA) has taken a decisive step in reinforcing its commitment to medical device safety and manufacturing integrity by issuing import alerts on a number of critical devices produced by Olympus Medical Systems Corporation and its affiliated subsidiaries in Japan. The FDA will keep the public Jun 25, 2025 · FDA is alerting health care providers about import alerts for medical devices manufactured in Japan by Olympus Medical Systems Corporation. At the start of the year, the U. . Feb 28, 2025 · Azurion Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The devices affected include certain bronchoscopes, laparoscopes, ureterorenoscopes Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. Devices listed on the Red List of this alert ***are either devices or which a 510 (k) application has not been filled and/or determined substantially equivalent, Class III medical device for which there is no Pre-Market Approval (PMA) for commercial distribution, or investigational device that lacks an Investigational Device Exemption (IDE). 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. Nov 28, 2023 · The FDA recently received medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while people are using Philips DreamStation 2 CPAP The Food and Drug Administration (FDA) routinely publishes a variety of alerts on its MedWatch system related to safety issues with pharma products. Food and Drug Administration (FDA) published import alerts for certain medical devices manufactured at the company’s Aizu facility in Fukushima, Japan. *** Nov 4, 2025 · FDA expands early alert program to cover all medical devices After a successful pilot, the agency has lifted the limitations on when it will provide early information about potentially high-risk safety events. FDA rolled out a new pilot initiative aimed at improving how and when the public is informed about potentially dangerous medical devices. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the Jan 30, 2025 · The FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors. Jun 25, 2025 · The Food and Drug Administration has blocked certain Olympus Medical devices from entering the U. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus Aug 6, 2025 · This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This action prevents the import of the specified devices into the U. The FDA has Mar 20, 2025 · This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. Language Assistance Available: | | | | | | | | | | | | | | | 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. FDA recall classification may occur after the firm recalling the Sep 12, 2025 · This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. Jun 25, 2025 · The FDA is notifying healthcare providers about import alerts for certain medical devices manufactured in Japan by Olympus. The FDA will keep the public Jun 27, 2025 · TOKYO, June 27, 2025 – On June 24, 2025 (U. Oct 10, 2025 · The FDA posts information about certain medical device recalls and early alerts to help increase awareness of these issues. Sep 23, 2024 · Medical Device Safety Alert: Issued in situations where a medical device may present an unreasonable risk of substantial harm. The Philips recall, one of the largest in the industry’s history, has been ongoing since Dec 26, 2023 · For food recalls, go to Recalls, Market Withdrawals, & Safety Alerts. The FDA will keep the public Aug 6, 2025 · This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has received medical device reports in which users Feb 6, 2025 · This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. This alert summarizes trends in the warning letters issued in the first quarter of 2024 (January through March). S. Ablation catheter update. Jan 30, 2025 · Olympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from 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 (FDA) has jurisdiction over recalls involving the following: FDA Recalls and Safety Alerts Sign up for FDA's Recall Subscription List How to report a problem with a product to FDA Medical Device Safety Communications The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. Jan 3, 2025 · In the final days of 2024, the Food and Drug Administration notified the public of safety issues involving medical devices from Olympus, Trokamed, Nuwellis and Baxter. The FDA and USDA Role in Mandatory Recalls Jul 25, 2025 · Medical Device Safety Alerts The Food and Drug Administration (FDA) routinely publishes a variety of alerts related to the safety of medical devices. Sep 30, 2025 · Officials announced a pilot of the initiative late last year. The FDA has become aware of a potentially high-risk device issue. 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 Sep 4, 2024 · Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona® Tracheostomy Tubes Nov 20, 2025 · If a user rapidly presses two or more on-screen buttons, the NOxBOXi Nitric Oxide Delivery System may experience sudden software interruption or restart. Medical Devices News and Updates about the regulations in Medical Devices Rules Mar 11, 2025 · This has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions rely on such data. Oct 2, 2025 · In November 2024, the FDA’s Center for Devices and Radiological Health launched the pilot program to improve the speed at which corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls are communicated to users. The pilot aims to improve the time between when the FDA first knows about certain corrective actions on products and when 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. Oct 3, 2025 · September 29, 2025 | Silver Spring, MD — The U. Feb 6, 2025 · The FDA advises patients to carefully follow instructions from diabetes device manufacturers when installing, setting up, or updating mobile medical apps on smartphones. Department of Health and Human Services U. Oct 31, 2024 · Medical device news-making events, videos, and meetings and conferences. Oct 1, 2025 · FDA has announced the expansion of its Early Alert Communications Program for medical devices, building on its 2024 pilot program aimed at minimizing the time between the Agency’s initial awareness of, and public communication regarding, potentially high-risk medical device removals or corrections. Changes are bracketed by asterisks (***). It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public). FDA Device Alerts Problems with medical devices may be caused when devices malfunction. To search archived content, visit Search FDA Archive and input the name of May 22, 2024 · Medical Device Safety and Recalls Notices on medical device recalls, safety communications, alerts, articles, and other safety information. Subscribe to receive FDA health fraud alerts Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective Mar 5, 2025 · The FDA posts a list of new Class I recalls on its website after the manufacturer takes action, along with early alerts for things that may be labeled Class I recalls later on. 29, 2025, and CDRH will now issue Early Alerts for potentially high-risk removals or corrections for all medical devices. Food and Drug Administration (FDA). This recall involves removing certain devices from where they are used or sold. The agency receives complaints and other safety-related information from health care providers, manufacturers, and consumers on its MedWatch program. FDA officials issued the import alerts Tuesday to prevent 58 models of Olympus devices used in urinary, respiratory, abdominal and pelvic procedures from reaching customers in the U. Nov 22, 2024 · The Food and Drug Administration’s medical device center unveiled Thursday a pilot program meant to speed up notices to the public about potentially high-risk product recalls. The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the Related Recalls Related Recalls - Plastic Syringes Made in China for Potential Device Failures [Español] [简体中文 (Simplified Chinese)] [Tagalog] Reporting Problems to the FDA If you think MedWatch RSS FeedFrequently Asked Questions: RSS What Is RSS? RSS stands for R eally S imple S yndication. The Medical Device Safety Action Plan outlines FDA’s innovation to improve safety, detect safety risks, and keep doctors and patients better informed. The early alert notices are part of an FDA pilot program launched in November designed to more quickly inform the public of potential high-risk device issues. Jul 15, 2025 · The FDA is aware that BD and their subsidiary CareFusion have issued an “Urgent Medical Device Recall (Correction)” letter notifying affected customers of worse performance, under certain use This client alert is the first in a series of alerts summarizing trends and otherwise notable allegations in publicly available FDA warning letters relating to medical devices. Dec 16, 2024 · Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement. Food and Drug Administration A to Z Index Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Mar 20, 2025 · Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. Dec 26, 2023 · For food recalls, go to Recalls, Market Withdrawals, & Safety Alerts. The FDA posted 12 new medical device recalls and one early alert in February. Dec 19, 2024 · The Food and Drug Administration’s recall process was a key topic for the medical device industry in 2024. Jun 25, 2025 · The FDA is shutting the door to imports of certain endoscope hardware manufactured by Olympus, saying that a production site in Japan has failed to meet quality requirements. The FDA issued the alert one day after BD wrote to customers to recommend actions to mitigate the risks posed by a system used to break up and remove clots from arteries. The FDA is alerting patients of a safety concern regarding diabetes devices that rely on a smartphone to deliver critical safety alerts. Government Accountability Office said it would look at the agency’s recall process, following Philips’ recall of more than 15 million respiratory devices. 1 Jun 24, 2025 · The US Food and Drug Administration (FDA) has issued import alerts for select Olympus Medical Systems devices manufactured in Japan due to unresolved concerns related to quality system regulation violations. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public Mar 5, 2025 · What to Do On December 20, 2024, Baxter sent all affected customers an Urgent Medical Device Recall letter recommending the following actions: Immediately check your stock for the affected product Mar 13, 2024 · Stay informed about the latest medical device safety alerts, FDA recalls, and regulatory updates. ” Olympus sent affected customers an Urgent Medical Device Advisory Notice letter on 18 December, with the FDA alert coming on the 23 December, as part of a communications pilot to enhance medical device recalls. Foreign inspection of device manufacturers are being performed and detention without physical examination (DWPE) may be appropriate when an FDA inspection has revealed that a firm is not Aug 14, 2025 · Import Alert 99-49 (Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer (s) and/or products (s) at issue. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc. Jan 13, 2025 · The U. Food and Drug Administration (FDA) has announced that Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry (MCOT) devices after certain high-risk electrocardiogram (ECG) events were never routed to trained cardiology technicians as intended. Dec 30, 2024 · This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. Mar 31, 2023 · Introduction The human factors literature defines an alarm as a signal intended to capture and direct human attention to a potential issue that may require monitoring, assessment, or intervention. The FDA will keep the public Aug 6, 2025 · Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. Feb 14, 2025 · Heart Pump Recall: Abiomed, Inc. Medical Devices: For a more complete listing of Medical Device Recalls, see FDA’s Medical Device Recalls. Dec 24, 2024 · The US Food and Drug Administration (FDA) has issued an alert relating to a problem with a component on endoscopes manufactured by Olympus that may be “high-risk. The FDA will keep the public Nov 14, 2025 · Safety Alerts The Food and Drug Administration (FDA) routinely publishes a variety of alerts related to the safety of medical devices, pharmaceuticals, biologics, vaccines, dietary supplements, and cosmetics. Since then, the agency has issued early alerts shortly after companies have told customers about issues with certain medical devices. In some cases, these situations also are considered recalls. ’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units Oct 16, 2025 · Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. The FDA will keep the public Jan 31, 2025 · The FDA posts information about certain medical device recalls and early alerts to help increase awareness of these issues. The pilot aims to minimize the time between the FDA’s initial awareness and public notification of potentially high-risk medical device removals or corrections. 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. Jan 13, 2025 · Info related to recall of medical devices, corrections and removals; regulations and Federal Register notices. Jun 25, 2025 · FDA has issued import alerts to prevent future shipments of certain Olympus medical devices made in Japan from entering the United States. 3 days ago · Page Last Updated: 11/18/2025 Note: If you need help accessing information in different file formats, see . | The FDA is shutting Main FDA Warning Letter PageLearn about the types of warning letters on FDA's website. Mar 31, 2025 · The FDA monitors reports of adverse events and other problems with medical devices and when needed, alerts patients, health care providers, industry, and the public. These items were Oct 31, 2025 · The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. because of quality system failings at a site in Japan. Jan 14, 2025 · Philips Monitoring Service Application processes mobile cardiac telemetry data but failed to send critical data for review by healthcare professionals. Import Alert # 99-49 Published Date: 08/14/2025 Type: DWPE This database contains Medical Device Recalls classified since November 2002. FDA News Release FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain Nov 20, 2025 · There may be nitric oxide dosing fluctuations and therapy interruption when NOxBOXi Nitric Oxide Delivery System is used with certain ventilators. The status is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is terminated. Food and Drug Administration (FDA) announced today a major regulatory shift that broadens its Medical Device Recall Communications Program to include all classes of medical devices, effective immediately. Figure 1: Image of PowerPICC Taper Region Check this web page for updates. It's an easy way for you to keep up with new safety information that's important to you Jun 24, 2025 · This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. Stress, wear, high temperatures, friction or localized pressure can cause part Jun 29, 2025 · The FDA is alerting healthcare providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical. Feb 10, 2025 · Dive Brief: The Food and Drug Administration published an early alert on Thursday about a BD device linked to 30 serious injuries and four deaths. This is a Class I recall, the FDA’s most serious classification. Sep 29, 2025 · After the success of the pilot, Early Alert communications expanded on Sept. Note: Revisions of this Import Alert dated 05/10/2021 updated the reason for alert section, guidance section, product description section, and charge section. The FDA is aware that BD and their subsidiary CareFusion have issued two “Urgent Medical Device Recall (Correction)” letters notifying affected customers of worse performance, under certain Oct 10, 2023 · Family Dollar is initiating a voluntary retail-level product recall of certain over-the-counter drugs and medical devices regulated by the U. This issue, which lasted from July 2022 Aug 15, 2025 · This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The agency receives complaints and other safety-related information from health care providers, manufacturers, and consumers on Medwatch, as well as notifications of safety issues from manufacturers. About us Home / Teams / Regulation and safety / Incidents and SF / Full List of WHO Medical Product Alerts Sep 20, 2024 · FDA drug alerts in pulmonology, including drug approvals/warnings, vaccine approvals, medical device recalls/updates, and drug label updates. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts. Jun 24, 2025 · The U. For updates and alerts on high-risk device issues, visit the FDA’s Medical Device Recalls page. hxovsw kzvwoo kitk lba kot pxybzo puh aiaohx tymp jpj rdixblw vnls kjdbd hlhorr hbnx