The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2023 Safety Communications Content current as of: 02/07/2023 Article source: http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications
Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ
Update – February 7, 2023: The Mammography Quality Standards Act (MQSA) certificate for Advanced Women Imaging, located at 6414 Bergenline Avenue, West New York, NJ (Bergenline) was revoked until January 4, 2025. The facility is currently unaccredited, uncertified, and cannot legally perform mammography. Additionally, the FDA has identified two individuals that qualify as owners or…
Daiso Issues Allergy Alert for Prepackaged Snacks
Summary Company Announcement Date: February 03, 2023 FDA Publish Date: February 03, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Daiso California LLC Brand Name: Brand Name(s) Daiso California LLC Product Description: Product Description Powdered apple tea, crackers, cookies & candy Company Announcement Daiso California LLC of…
Titans Global Inc Issues Allergy Alert on Undeclared Egg in “JSJ Chocolate Cake”, “JSJ Zsr Cake”, “JSJ DMC Leaf Cake”
Summary Company Announcement Date: February 06, 2023 FDA Publish Date: February 06, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description undeclared egg Company Name: Titans Global Inc Brand Name: Brand Name(s) Product Description: Product Description Company Announcement Titans Global Inc ISSUES ALLERGY ALERT ON UNDECLARED EGG IN “JSJ Chocolate Cake”, “JSJ…
Kerry Inc. Pleads Guilty and Agrees to Pay $19.228 Million in Connection with Insanitary Plant Conditions Linked to 2018 Salmonella Poisoning Outbreak
U.S. Department of Justice FOR IMMEDIATE RELEASEFriday, February 3, 2023 Food and ingredient manufacturing company Kerry Inc. pleaded guilty today to a charge that it manufactured breakfast cereal under insanitary conditions at a facility in Gridley, Illinois, that was linked to a 2018 salmonellosis outbreak. Pursuant to a plea agreement filed with a criminal information…
Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or Under-Delivery of Therapy
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: CADD infusion system Administration Sets and Cassette Reservoirs Product Models: See Medical Device Recall Database entries Distribution Dates: June 15, 2018 to present Devices Recalled…
Missouri Doctor Admits Diluting Clinic’s Methadone
Department of JusticeU.S. Attorney’s OfficeEastern District of Missouri FOR IMMEDIATE RELEASEFriday, February 3, 2023 ST. LOUIS – A doctor admitted on Friday that he diluted methadone that was dispensed in a St. Francois County, Missouri methadone clinic in 2021. Dr. Sunil G. Chand, 59, pleaded guilty in front of U.S. District Judge Sarah E. Pitlyk…
Fresh Ideation Food Group LLC Recalls Sandwiches and Other Products Because of Possible Health Risk
Breakfast Bacon, Egg & Cheddar Muffin Bistro to Go 813141023070 02/02/2023 to 02/06/2023 Breakfast Bacon, Egg & Cheddar Muffin Quick & Fresh 813141023070 02/06/2023 to 02/06/2023 Breakfast Bacon, Egg & Cheddar Muffin Westin Label 813141023070 02/06/2023 to 02/06/2023 Breakfast Bacon, Egg & Cheese Bialy Fresh Creative Cuisine Black Label 813141027757 01/31/2023 to 02/02/2023 Breakfast Bacon,…
Daiso Issues Alergy Alert for Prepackaged Snacks
Summary Company Announcement Date: February 03, 2023 FDA Publish Date: February 03, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Daiso California LLC Brand Name: Brand Name(s) Daiso California LLC Product Description: Product Description Powdered apple tea, crackers, cookies & candy Company Announcement Daiso California LLC of…
Three Individuals and One Company Indicted for Introducing Adulterated and Misbranded Devices into Interstate Commerce and Mail Fraud Conspiracy
Department of JusticeU.S. Attorney’s OfficeDistrict of Puerto Rico FOR IMMEDIATE RELEASEFriday, February 3, 2023 The defendants are facing a forfeiture allegation of $327,047.56 SAN JUAN, Puerto Rico – A federal grand jury in the District of Puerto Rico returned an indictment on February 1, 2023 charging Elberto Berdut-Teruel, Wanda L. Carballo-Cabrera, María Santos-Carballo, and Magnetic…