Correction Alert: Olympus Updates Use Instructions for Ligating Device
Olympus ligation loops may be unable to release or detach as expected during use and may become unintentionally anchored around patient anatomy
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Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care
Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may provide incorrect low glucose readings
Recall Alert: Glycar SA Removes Pericardial Patch
Certain SJM Pericardial Patches from Glycar SA may not meet the required tensile strength specification
Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue
Dropping or severely jarring Alaris Pumps may damage critical pump components. Do not use dropped or jarred devices until thoroughly inspected and tested
Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform
Balt USA is removing their Mega Ballast because of the unintended presence of loose hydrophilic coating inside the tube at the tip end
Recall Alert: Baxter Permanently Removes Life2000 Ventilation System
Baxter is permanently removing all Life2000 Ventilation Systems after discovering a cybersecurity issue that may allow unauthorized access to the device
Recall Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices
SpeedControl Dials used with SmartDrive MX2+ Power Assist Devices may be unresponsive to users and fail to stop or start unexpectedly, causing injury
Early Alert: Large Volume Pump Primary Administration Set Reverse Flow Issue from Fresenius Kabi
Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications
Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles
Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.
Recall Alert: Intersurgical Inc Removes i-View Video Laryngoscope
Intersurgical is recalling the i-View Video Laryngoscope due to the device not turning on, battery liquid leakage and screen going blank.
Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits
Medline is recalling certain Convenience Kits due to being labeled as sterile but not having gone through the sterilization process
Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Risk for Nitric Oxide Dosing Fluctuations
There may be nitric oxide dosing fluctuations and therapy interruption when NOxBOXi Nitric Oxide Delivery System is used with certain ventilators.
Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Rapid Command Input Issue
If a user rapidly presses two or more on-screen buttons, the NOxBOXi Nitric Oxide Delivery System may experience sudden software interruption or restart.
Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set
B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System
Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting system
Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols - FDA Safety Communication
These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.
Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples
FOR IMMEDIATE RELEASE – Nov. 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg
Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment
CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment durin
Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection
FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product
WHO calls for a new era of strategic urban health action with global guide to unlock healthy, prosperous and resilient societies
With the new guide for decision-makers launched today, WHO provides concrete ideas to usher in a new era of urban health action. The Guide responds to the growing demand for integrated solutions that address health challenges and promote health more broadly in urban settings.
Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication
Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.
WHO condemns killings of patients and civilians amid escalating violence in El Fasher, Sudan
The World Health Organization (WHO) condemns the reported killing of more than 460 patients and their companions, as well as the abduction of six health workers, on 28 October from the Saudi Maternity Hospital in El Fasher. This latest tragedy is taking place in the rapidly worsening crisis in North Darfur’s El Fasher, where escalating violence, siege conditions and rising hunger and disease are killing…
Climate inaction is claiming millions of lives every year, warns new Lancet Countdown report
WHO and global partners are calling for the protection of people’s health to be recognized as the most powerful driver of climate action, as a new global report released today warns that continued overreliance on fossil fuels and failure to adapt to a heating world are already having a devastating toll on human health.The 2025 report of the Lancet Countdown on Health and Climate Change, produced in collaborati…
Fiji becomes the 26th country to eliminate trachoma as a public health problem
In a landmark public health achievement, Fiji has been validated by the World Health Organization (WHO) for eliminating trachoma as a public health problem. Trachoma, a neglected tropical disease (NTD) and the world’s leading infectious cause of blindness, no longer poses a public health threat in the country.Trachoma is the first NTD to be eliminated in Fiji. Fiji is the 26th country to eliminate trachoma as …
Health Works Leaders Coalition launched to promote health system investments and spur economic growth, job creation
The World Bank Group, the Government of Japan, and the World Health Organization officially launched the Health Works Leaders Coalition. This global alliance brings together health and finance ministers, philanthropic organizations, business leaders, leaders of global health agencies, and civil society representatives with the aim of promoting investments in health systems as a strategy for economic growth, job crea…
Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication
FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices; asks for reports of injuries related these devices
WHO and the European Union launch collaboration to advance digitized health systems in sub-Saharan Africa
The World Health Organization (WHO) and the European Union (EU) announced today a new agreement to support the digital transformation of health systems and wider adoption of WHO’s Global Digital Health Certification Network (GDHCN) in sub-Saharan Africa. This EU–WHO partnership will improve pandemic preparedness and accelerate progress towards better health and well-being for all.
WHO upgrades its public health intelligence system to boost global health security
Today, the World Health Organization (WHO), in collaboration with key partners and supporters, launched version 2.0 of the Epidemic Intelligence from Open Sources (EIOS) system, used globally for the early detection of public health threats.
11 million lives lost each year: urgent action needed on neurological care
The World Health Organization (WHO) today warns that less than one in three countries around the world has a national policy to address the growing burden of neurological disorders, responsible for over 11 million deaths globally each year. The WHO’s new Global status report on neurology released today shows that neurological conditions now affect more than 40% of the global population – over 3 billion people.
Maldives becomes the first country to achieve ‘triple elimination’ of mother-to-child transmission of HIV, syphilis and hepatitis B
In a landmark public health achievement, the World Health Organization (WHO) has validated the Maldives for eliminating mother-to-child transmission (EMTCT) of hepatitis B, while maintaining its earlier validation (in 2019) for EMTCT of HIV and syphilis.
WHO warns of widespread resistance to common antibiotics worldwide
One in six laboratory-confirmed bacterial infections causing common infections in people worldwide in 2023 were resistant to antibiotic treatments, according to a new World Health Organization (WHO) report launched today. Between 2018 and 2023, antibiotic resistance rose in over 40% of the pathogen-antibiotic combinations monitored, with an average annual increase of 5–15%. Data reported to the WHO Global…
FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)
The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.
Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed
Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller
Trividia Health, Inc. Initiates Voluntary Recall of Limited Number of TRUE METRIX® Blood Glucose Meters
(FT. LAUDERDALE, FL) –October 7, 2025 – Trividia Health, Inc., announced today that it is initiating a voluntary recall of a limited number of TRUE METRIX® Self-Monitoring Blood glucose meters co-branded under the Good Neighbor Pharmacy® brand and distributed in the United States.
CDC Immunization Schedule Adopts Individual-Based Decision-Making for COVID-19 and Standalone Vaccination for Chickenpox in Toddlers
CDC updated updated its adult and child immunization schedules to apply individual-based decisions
WHO tobacco trends report: 1 in 5 adults still addicted to tobacco
The world is smoking less, but the tobacco epidemic is far from over. A new WHO global report shows the number of tobacco users has dropped from 1.38 billion in 2000 to 1.2 billion in 2024. Since 2010, the number of people using tobacco has dropped by 120 million – a 27% drop in relative terms. Yet, tobacco still hooks one in five adults worldwide, fuelling millions of preventable deaths every year.&…
Global health agencies issue new recommendations to help end deaths from postpartum haemorrhage
Through landmark new guidelines released today, leading reproductive health agencies are calling for a major shift in how postpartum haemorrhage (PPH) is prevented, diagnosed and treated. The recommendations highlight the urgent need for earlier detection and faster intervention – steps that could save the lives of tens of thousands of women each year.Defined as excessive bleeding after childbirth, PPH affects…
Statement from Laura Chanchien Parajón, MD, MPH, Director (Acting), CDC's National Center for Chronic Disease Prevention and Health Promotion, on the passing of Suzy Ellis, Tips From Former Smokers® participant
We extend our deepest condolences to Suzy's family, her friends, and all who cared about her.
Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips
Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.
What is a Medical Device Recall?
What is a Medical Device Recall?
What is an Early Alert?
Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk medical device removal or correction and FDA’s public communication
Recall and Alert Resources
.This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices
Update on Alert: Infusion Set Performance Issue from BD
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
Listeria Outbreak to include more Prepared Foods
CDC Expands Listeria Outbreak Alert to Include Additional Prepared Foods
Recommendations announced for influenza vaccine composition for the 2026 southern hemisphere influenza season
The World Health Organization (WHO) today announced its recommendations for the viral composition of influenza vaccines for use in the 2026 influenza season in the southern hemisphere. The announcement was made at an Information Meeting after a 4-day Consultation on the Composition of Influenza Virus Vaccines.
Member States advance vital work in support of WHO Pandemic Agreement
WHO Member States are actively progressing with the development of the Pathogens Access and Benefit Sharing (PABS) system, a key component of the WHO Pandemic Agreement aimed at ensuring equitable and timely sharing of pathogen materials and related benefits. This work follows the historic adoption of the WHO Pandemic Agreement and amendments to the International Health Regulations, marking significant steps toward …
World leaders show strong support for political declaration on noncommunicable diseases and mental health
World leaders have expressed overwhelming support for the text of the first United Nations global political declaration on responding to noncommunicable diseases (NCDs) and mental health in an integrated manner. The declaration, negotiated during a five-month intergovernmental process, will be considered at the 80th session of the General Assembly for final approval in October 2025.
CDC Reports Latest National Data on Syphilis in Newborns and Sexually Transmitted Infections (STIs)
New CDC data shows U.S. cases of newborn syphilis increased for the 12th consecutive year in 2024
WHO statement on autism-related issues
The World Health Organization (WHO) emphasizes that there is currently no conclusive scientific evidence confirming a possible link between autism and use of acetaminophen (also known as paracetamol) during pregnancy. Globally, nearly 62 million people (1 in 127) have autism spectrum disorder, a diverse group of conditions related to development of the brain. Although awareness and diagnosis have improved in re…
Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System
3M is correcting their Ranger Blood/Fluid Warming System due to incomplete temperature and flow rate specifications on the label.
CDC Report Finds Sharp Rise in Dangerous Drug-Resistant Bacteria
A CDC report found a dramatic increase in a dangerous type of drug-resistant bacteria.
Uncontrolled high blood pressure puts over a billion people at risk
The World Health Organization (WHO) today released its second Global hypertension report, showing that 1.4 billion people lived with hypertension in 2024, yet just over one in five have it under control either through medication or addressing modifiable health risks.
Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed
FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues
EU renews support for WHO’s Universal Health Coverage Partnership
WHO and the European Union (EU) have renewed their collaboration on achieving universal health coverage with the launch of Phase V (2025–2028) of the Universal Health Coverage (UHC) Partnership – WHO’s largest platform for strengthening health systems and advancing primary health care.
Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles
CENTER VALLEY, Pa., (September 19, 2025) — Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) manufactured prior to May 12, 2025, after receiving reports of device components detaching during procedures
Amended International Health Regulations enter into force
Today marks a milestone in global health governance as the amendments to the International Health Regulations (IHR) enter into force. This reflects a renewed global commitment to cooperation in the face of public health emergencies, shaped by hard-earned lessons of the COVID-19 pandemic.
Statement from Laura Chanchien Parajón, MD, MPH, Director (Acting), CDC's National Center for Chronic Disease Prevention and Health Promotion, on the passing of Michael Fletcher, Tips From Former Smokers® participant
Michael Fletcher, a passionate advocate for quit-smoking efforts, has passed away
WHO urges cost effective solutions on NCDs and mental health amidst slowing progress
The World Health Organization (WHO) today released a new report titled “Saving lives, spending less”, revealing that an additional investment of just US$3 per person annually in tackling noncommunicable diseases (NCDs) could yield economic benefits of up to US$1 trillion by 2030.
Early Alert: TactiFlex Ablation Catheter Issue from Abbott
Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues
FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025
FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. Retailers Should Not Sell and Consumers Should Not Use Certain Cookware Because of Their Potential to Leach Lead into Food When Cooking
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