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MedWatch Safety Alert

2020 Medical Device Recalls

List of Medical Device recalls in 2020.

LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue

LeMaitre is recalling the Over the Wire Embolectomy Catheter because of the possibility of difficulty in balloon deflation during use.

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.

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 use.

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, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is b

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 Disease 2019 (COVID-19) outbreak.