The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a voluntary correction, not a product removal. Recalled Product Product Names and Product Codes: Impella 5.0 Blood Pump, Product Number 005062 Impella CP…
Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Amplatzer Steerable Delivery Sheath Product Model: ASDS-14F-075 Distribution Dates: October 4, 2022 to February 22, 2023 Devices Recalled in the U.S.: 672 Date Initiated by…
Contact Lenses: Safe Use of Hydrogen Peroxide Solution
Image Español If you wear contact lenses, the way you clean and disinfect them can affect your vision and health. Following instructions from your eye care professional and from the contact lens solution manufacturer are especially important if you use a solution that contains hydrogen peroxide. Hydrogen Peroxide Solution Contact lens solutions are sold over…
South Florida Resident Sentenced in Elaborate Prescription Medication Diversion Scheme
Department of JusticeU.S. Attorney’s OfficeSouthern District of Florida FOR IMMEDIATE RELEASETuesday, July 25, 2023 MIAMI – A 37-year-old South Florida resident, Eladio Vega, was sentenced yesterday to 87 months in prison, followed by three years of supervised release, for his role in a widespread fraud scheme involving the distribution of adulterated and misbranded cancer, HIV,…
Thoroughbred Racehorse Trainer Jason Servis Sentenced to Four Years in Prison
Department of JusticeU.S. Attorney’s OfficeSouthern District of New York FOR IMMEDIATE RELEASEWednesday, July 26, 2023 Damian Williams, the United States Attorney for the Southern District of New York, announced that defendant JASON SERVIS was sentenced to four years in prison today for his role in a years-long scheme in which horses trained by SERVIS were…
Rich Products Issues Allergy Alert on Undeclared Egg and Soy in Member’s Mark™ Breaded Mozzarella Sticks
Summary Company Announcement Date: July 25, 2023 FDA Publish Date: July 25, 2023 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared egg and soy Company Name: Rich Products Brand Name: Brand Name(s) Member’s Mark Product Description: Product Description Member’s Mark Breaded Mozzarella Sticks Company Announcement Rich Products of Buffalo, NY…
Leader of “Genesis II Church of Health and Healing,” Who Sold Toxic Bleach as Fake “Miracle” Cure for COVID-19 and Other Serious Diseases, Guilty of Conspiracy to Defraud the United States
Department of JusticeU.S. Attorney’s OfficeSouthern District of Florida FOR IMMEDIATE RELEASEFriday, July 21, 2023 MIAMI – A federal jury in Miami has found Mark Grenon, 65, and his three sons, Jonathan Grenon, 38, Jordan Grenon, 29, and Joseph Grenon, 36, guilty of conspiracy to defraud the United States by distributing an unapproved and misbranded drug….
Cooperstown Cheese Company Recalls Products Because of Possible Health Risk
Summary Company Announcement Date: July 21, 2023 FDA Publish Date: July 21, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential Listeria monocytogenes contamination Company Name: Cooperstown Cheese Company LLC Brand Name: Brand Name(s) Cooperstown Cheese Company Product Description: Product Description Cheese Products Company Announcement Cooperstown Cheese Company of Milford, NY,…
Employee of Medical Device Manufacturer Pleads Guilty to Forging Two FDA Clearance Letters for Medical Devices
U.S. Department of Justice FOR IMMEDIATE RELEASEThursday, July 20, 2022 A Philadelphia-area man pleaded guilty today for his role in distributing medical devices without U.S. Food and Drug Administration (FDA) clearance, the Department of Justice announced.Peter Stoll III, 34, pleaded guilty to one felony count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by…
Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication
Date Issued: July 17, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, or Well-Being Reality. The devices have not been reviewed by the FDA. The safety and effectiveness of these devices have not been established to diagnose, treat, or…