Department of JusticeU.S. Attorney’s OfficeOffice of Public Affairs FOR IMMEDIATE RELEASETuesday, March 5, 2024 A former raw milk cheese manufacturer and the company he owned and managed pleaded guilty today to charges related to cheese that was linked to a 2016-2017 outbreak of listeriosis, the disease caused by the pathogen Listeria monocytogenes. Johannes Vulto and his…
Pennsylvania Family Pleads Guilty to Fentanyl Trafficking
Department of JusticeU.S. Attorney’s OfficeEastern District of Virginia FOR IMMEDIATE RELEASETuesday, March 5, 2024 ALEXANDRIA, Va. – Three members of a Tobyhanna, Pennsylvania, family pleaded guilty today to conspiring to distribute fentanyl. According to court documents, Hadja Franklin, 55, Nabyunissa Bangoura (“Nabyunissa”), 34, Tanziludin Bangurah (“Tanziludin”), 52, manufactured counterfeit oxycodone and Xanax in a laboratory in…
Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions
Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: Medfusion syringe pump Product Codes: FRN Model Numbers: Model 3500 syringe pump Distribution Dates: August 9, 2002 to August 15, 2023 Devices Recalled in the U.S.: 85,961 Date Initiated by Firm: December 19, 2023 Device Use The Medfusion Model…
Follow Instructions for Safe Use of Electrical Operating Room Tables – Letter to Health Care Providers
February 29, 2024 The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers and facilities about the safe use of electrical operating room tables. The FDA has received reports of adverse events associated with electrical operating room tables and is providing recommendations for health care providers to help protect patients. …
Maine Man Indicted for Lacing Ice Cream with THC at Newmarket Café
Department of JusticeU.S. Attorney’s OfficeDistrict of New Hampshire FOR IMMEDIATE RELEASEThursday, February 29, 2024 CONCORD – A Maine man was indicted in connection with tampering with consumer products, First Assistant United States Attorney Jay McCormack announces. Marc Flore, 43, was indicted on one count of tampering with consumer products. Flore will appear in federal court in…
Opioid Manufacturer Endo Health Solutions Inc. Agrees to Global Resolution of Criminal and Civil Investigations into Sales and Marketing of Branded Opioid Drug
Department of JusticeU.S. Attorney’s OfficeOffice of Public Affairs FOR IMMEDIATE RELEASEThursday, February 29, 2024 United States Also Reaches Settlement with Endo International in Bankruptcy Case Endo Health Solutions Inc. (EHSI), which is in bankruptcy, has agreed to resolve criminal and civil investigations related to the company’s sales and marketing of the opioid drug Opana ER…
Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication
Date Issued: February 29, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about a higher-than-expected risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system, manufactured by DT MedTech LLC. The FDA is evaluating interim post-approval study (PAS) results for the Hintermann Series…
Megadyne Reiterates Intended Use Population Change for Megadyne Mega Soft Universal and Universal Plus Patient Return Electrodes
Summary Company Announcement Date: February 29, 2024 FDA Publish Date: February 29, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Limit use to patients aged 12 years or older. Company Name: Megadyne Medical Products, Inc. Brand Name: Brand Name(s) Product Description: Product Description Mega Soft Universal and Universal Plus Reusable Patient Return…
Datex-Ohmeda Recalls EVair Air Compressors Due to Formaldehyde Emissions Found in Specific Conditions When Used with CARESCAPE R860, Engstrom Carestation or Pro Ventilators
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 Names: EVair air compressors (model numbers M1230849, M1230847) EVair-03 air compressors (Jun-air; model numbers 1609000, 1609002) EvAir CPRSR Kits (model numbers M1230849, M1230847) Product Codes: See…
Roland Foods, LLC Recalls Roland® Tahini (100% Ground Sesame Seeds) 16 Oz. Because of Possible Health Risk
Summary Company Announcement Date: February 27, 2024 FDA Publish Date: February 28, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella. Company Name: Roland Foods, LLC. Brand Name: Brand Name(s) Product Description: Product Description Company Announcement Roland Foods, LLC (“Roland Foods”) of New York, New York…