Medical Device Recalls | FDA - U.S. Food and Drug Administration
WEBIf you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database.
Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators
WEB5 days ago · This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you ...
Medical Device Recalls - Food and Drug Administration
WEB5 days ago · This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the...
Recalls, Corrections and Removals (Devices) | FDA
WEBYou must contact your FDA’s Office of Regulatory Affairs (ORA) Division Recall Coordinator (DRC) listed here by state or region (look for Product Type “Medical Device”). Foreign ...
FDA announces recall of heart pumps linked to deaths and injuries
WEBApr 16, 2024 · A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA's most serious recall, the agency announced Monday.
Medical Device Recall Information - Philips Respironics Sleep and ...
WEBGlobally, we have remediated 99% of actionable* sleep therapy device registrations to date. As the remediation of the ventilator devices continues, Philips Respironics will be communicating with Durable Medical Equipment providers …
Medical Device Recalls - Food and Drug Administration
WEBSep 10, 2024 · Medical Device Recalls. This database contains the classified Medical Device Recalls since november 1, 2002. to search, enter a single word (e.g., electromechanical), an exact phrase...
Reforming The Medical Device Recall Process—A Call For …
WEBFeb 15, 2024 · When recalls occur, manufacturers must identify the affected devices, assess the likely cause, and propose a strategy of corrective actions (e.g., repairing or replacing devices).
Most recalled cardiovascular devices gained FDA approval with …
WEB2 days ago · Kadakia et al. explored data from a total of 137 Class I recall events that affected 157 different cardiovascular devices. A majority (71.3%) of devices gained approval through the FDA’s 510 (k) pathway, meaning the manufacturer had to prove it was similar to devices already being marketed in the United States.
GAO Will Open Investigation Into FDA Oversight of Medical Device ...
WEBJan 17, 2024 · Congressional investigators are launching an inquiry into the Food and Drug Administration’s oversight of medical device recalls for the first time in years following reports that the agency...
Skip to content