MedWatch Safety Alerts

All Ranitidine Products (Zantac): Press Release - FDA Requests Removal

The FDA announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately

2020 Medical Device Recalls

List of Medical Device recalls in 2020

Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture

Medtronic is recalling their Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the device could fracture during

CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion

The infusion pumps deliver fluids and medications. The affected infusion pumps and infusion pump systems lead to over- and under-infusion in patients

Dr. Reddy's Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening

Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904

Fecal Microbiota for Transplantation: Safety Alert - Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19

FDA is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT

Ventilator Supply Mitigation Strategies: Letter to Health Care Providers

Recommendations for health care providers and facilities in treating patients who require ventilation assistance due to COVID-19 complications

Medical Glove Conservation Strategies: Letter to Health Care Providers

FDA recognizes that the need for personal protective equipment (PPE), such as medical gloves, may outpace the supply available to health care organizations during the Coronavirus

CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion

CME America, a wholly owned subsidiary of Becton Dickinson, Recalls BodyGuard Microset Infusion Sets Due to Risk of Under-infusion

Natural Remedy Store Issues Voluntary Worldwide - Recall of Active Male Due to Presence of Undeclared Tadalafil

Natural Remedy Store is voluntarily recalling all lots of Active Male, 500mg capsules to the consumer level. FDA analysis has found the product to be tainted with undeclared

Fecal Microbiota for Transplantation: Safety Alert - Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms

FDA is informing health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT

Surgical Mask and Gown Conservation Strategies - Letter to Healthcare Providers

The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available

BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris

Voluntary Field Corrective Action of HiRes Ultra and Ultra 3D

Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has begun notifying regulatory authorities that it will voluntarily

Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors

Recalled due to multiple system errors, software errors, and use-related errors which can lead to delay in infusion, interruption of infusion, slower than expected delivery of

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates

Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is

Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning - Due to Restricting Use for Allergic Rhinitis

FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and

2020 Safety Communications

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

SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety Communication

Learn about the SweynTooth cybersecurity vulnerabilities associated with Bluetooth Low Energy (BLE) and recommendations for patients, health care providers, and manufacturers

King Systems Recalls King Vision Video Laryngoscope Adapter Size ½ Due to a Display of The Reversed Image

The device shows an image on the display while examining a patient’s upper airway. A reverse image is displayed which could cause potential injury

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