This recall involves correcting devices, and does not involve removing them 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 continue to use it without correction. Affected Product Product Names: Ivenix Infusion System (IIS) LVP Software…
IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug
This recall involves updating instructions for using these devices, and does not involve removing them 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 continue to use it without following the updated instructions. Affected Product Product…
Founder and Chief Executive Officer of Injectable Stem Cell Product Manufacturer Sentenced for Distributing Unapproved Drug
Department of JusticeOffice of Public Affairs FOR IMMEDIATE RELEASEMonday, September 30, 2024 The founder and chief executive officer of a California-based company that marketed stem cell-based products allegedly linked to 19 hospitalizations was sentenced today to 36 months in prison following his conviction under the Federal Food, Drug and Cosmetic Act. John W. Kosolcharoen, 53,…
South Florida U.S. Attorney’s Office Charges an Attorney, Former SBA Employee, Tax Preparer, and others with COVID-19 Fraud Schemes
Department of JusticeU.S. Attorney’s OfficeSouthern District of Florida FOR IMMEDIATE RELEASEMonday, October 30, 2024 MIAMI – The U.S. Attorney’s Office for the Southern District of Florida remains a leader in COVID-19 pandemic relief prosecutions, holding a range of actors accountable for these crimes. Over this summer alone, the district has charged 17 individuals with COVID-19…
Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation
This recall involves correcting devices, and does not involve removing them 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 continue to use it without correction. Affected Product Product Names: Trilogy Evo, Trilogy EV300, Trilogy Evo…
Yummy Foods Issues Allergy Alert on Traces of Milk Allergen in Non-Dairy Ices
Summary Company Announcement Date: August 07, 2024 FDA Publish Date: August 07, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared Milk Allergen Company Name: Yummy Foods Brand Name: Brand Name(s) Product Description: Product Description Yummy Swirly Ices, various flavors Company Announcement Yummy Foods, In Edison, NJ is recalling their…
Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement
Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement This recall involves correcting devices, and does not involve removing them 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…
Too Good Gourmet Issues Allergy Alert on Undeclared Milk in Meijer Dunking Cookies Chocolate Chip 10oz
Summary Company Announcement Date: August 09, 2024 FDA Publish Date: August 09, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Too Good Gourmet Brand Name: Brand Name(s) Product Description: Product Description Dunking Cookies Chocolate Chip Company Announcement August 9, 2024 – Too Good Gourmet of San…
Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector
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 continue to use it. Affected Product Product Names: PneuPAC paraPAC Plus P300 and P310 Ventilators Unique Device Identifier (UDI)/List Number: /P300NXX*,…
Prime Food Processing LLC Issues Allergy Alert on Undeclared Sesame in Steam Buns with Egg Custard Added and Steam Buns with Egg Custard and Coconut Added
Summary Company Announcement Date: August 09, 2024 FDA Publish Date: August 09, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared sesame Company Name: Prime Foods Processing LLC Brand Name: Brand Name(s) Prime Foods Product Description: Product Description Steam Buns with Egg Custard Added & Steam Buns with Egg Custard…