The FDA has labeled Smiths Medical's recall of ProPort Implantable Plastic Port as Class I, the most serious kind.
Problematic software has been the cause of multiple infusion pump recalls in the medical device industry over the past few years.
Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...
Jesy Nelson is undergoing an emergency procedure to save her unborn twins. The 33-year-old pop star recently revealed that she's been diagnosed with pre-twin-to-twin transfusion syndrome - a ...
On March 2, 2022, new amendments to the Medical Devices Regulations came into force. With these amendments, manufacturers and importers must report shortages and discontinuations that may lead to a ...
Ocean, Oasis, Express and Autotransfusion Chest Drains Chest drainage systems Atrium Medical Corporation Discontinued ... Medical Corporation Discontinued 2023-01-31 Table 2 Footnote 1 Device ...
If you or a loved one suffered an injury related to a recalled or defective medical device, Sokolove Law may be able to help you pursue compensation. A defective product may not be part of a recall.
Medical device recall events in 2024 reached their highest level since 2020 and more than 10% of them involved the most serious type of recall. There were 1,048 medical device recalls in 2024 ...
Beginning Friday night, FDA employees overseeing medical devices, food ingredients and other key areas ... working for the agency and weren’t authorized to discuss its internal procedures. The ...
The agency changed course just days after firing employees who oversee the safety of food and life-sustaining medical devices. Dozens of workers said they and others were back at work Monday.