US / FDA updates on medical device regulation and quality.
168 articles
Olympus Corporation has announced a voluntary corrective action involving bronchoscopes used in conjunction with certain high-risk therapeutic procedures. This update…
The U.S. Food and Drug Administration (FDA) has announced significant regulatory steps to enhance child safety, restricting the sale of…
The U.S. Food and Drug Administration (FDA) has released an updated safety communication regarding the Hintermann Series H3 Total Ankle…
The U.S. Food and Drug Administration (FDA) has announced measures to streamline the development of biosimilar drugs. These steps aim…
Zingerman’s Candy Manufactory, based in Ann Arbor, Michigan, has issued an urgent recall concerning two of its candy bar products,…
E.A. Sween Company has initiated a recall of its Deli Express® BBQ Pulled Pork sandwiches after discovering the potential presence…
On October 27, 2025, Purity Products, based in Plainview, NY, issued a voluntary recall of one lot of its dietary…
The U.S. Food and Drug Administration (FDA) has taken an important regulatory step to address New World screwworm infestations among…
The U.S. Food and Drug Administration (FDA) has officially published internal filing checklists utilized by its Center for Drug Evaluation…
Jody’s Inc. has issued a nationwide recall of its Cabot Creamery Sea Salt Caramel Cheddar Popcorn (6 oz bags) due…
On October 15, 2025, Publix Super Markets issued a voluntary recall of its Rich & Creamy Vanilla Ice Cream in…
On October 17, 2025, Jody’s Inc., a Norfolk, Virginia-based company, announced the voluntary recall of its Cabot Creamery Sea Salt…