1. 2020 Medical Device Recalls

    List of Medical Device recalls in 2020.
  2. Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment

    The catheter tip can become detached during a patient procedure which could lead to serious injury or death.
  3. 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 to healthcare organization during the Coronavirus Disease 2019 (COVID-19) outbreak.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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
  10. 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)

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