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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 Disease 2019 (COVID-19) outbreak.
Author: FDA
Posted: April 4, 2020, 4:00 am
List of Medical Device recalls in 2020.
Author: FDA
Posted: April 2, 2020, 1:00 pm
LeMaitre is recalling the Over the Wire Embolectomy Catheter because of the possibility of difficulty in balloon deflation during use.
Author: FDA
Posted: April 2, 2020, 4:00 am
The FDA announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.
Author: FDA
Posted: April 1, 2020, 4:00 pm
The infusion pumps deliver fluids and medications. The affected infusion pumps and infusion pump systems lead to over- and under-infusion in patients.
Author: FDA
Posted: March 30, 2020, 4:00 am
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 use.
Author: FDA
Posted: March 30, 2020, 4:00 am
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, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is b
Author: FDA
Posted: March 26, 2020, 4:00 am
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)
Author: FDA
Posted: March 23, 2020, 4:00 pm
Recommendations for health care providers and facilities in treating patients who require ventilation assistance due to COVID-19 complications
Author: FDA
Posted: March 22, 2020, 4:00 am
CME America, a wholly owned subsidiary of Becton Dickinson, Recalls BodyGuard Microset Infusion Sets Due to Risk of Under-infusion
Author: FDA
Posted: March 18, 2020, 3:00 pm
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 tadalafil
Author: FDA
Posted: March 16, 2020, 4:00 am
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)
Author: FDA
Posted: March 12, 2020, 5:00 pm
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 to healthcare organization during the Coronavirus Disease 2019 (COVID-19) outbreak.
Author: FDA
Posted: March 11, 2020, 4:00 am
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 initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices
Author: FDA
Posted: March 10, 2020, 4:00 am
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™ System regarding software for the PC Unit and certain modules. BD has notified customers affected by this recall, and the
Author: FDA
Posted: March 10, 2020, 4:00 am
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 medication (under-infusion), and faster than expected delivery of medication (over-infusion).
Author: FDA
Posted: March 6, 2020, 10:00 am
Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots (listed below) of Ketorolac Tromethamine Injection USP 30
Author: FDA
Posted: March 5, 2020, 5:00 am
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 allergy.
Author: FDA
Posted: March 4, 2020, 6:00 pm
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.
Author: FDA
Posted: March 3, 2020, 12:00 pm
Learn about the SweynTooth cybersecurity vulnerabilities associated with Bluetooth Low Energy (BLE) and recommendations for patients, health care providers, and manufacturers.
Author: FDA
Posted: March 3, 2020, 5:00 am