Summary Company Announcement Date: August 12, 2025 FDA Publish Date: August 13, 2025 Product Type: Food & Beverages Cheese/Cheese Product Foodborne Illness Reason for Announcement: Recall Reason Description Due to the presence of rodent, rodent activity, and other insanitary conditions during the manufacturing and storage process Company Name: Quesito El Establo Brand Name: Brand Name(s)…
Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps
Summary Company Announcement Date: August 07, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery Company Name: Tandem Diabetes Care, Inc. Brand Name: Brand Name(s) Tandem Diabetes Care, Inc. Product Description: Product…
Dollar General Announces Voluntary Recall of Clover Valley® Instant Coffee Due to Potential Presence of Glass
Summary Company Announcement Date: August 11, 2025 FDA Publish Date: August 12, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential presence of glass Company Name: Dollar General Corporation Brand Name: Brand Name(s) Clover Valley Product Description: Product Description Instant coffee Company Announcement Goodlettsville, Tennessee – August 11, 2025 –Dollar General…
Wegmans Food Markets, Inc. Recalls Various Wegmans Camembert Soft Ripened Cheese Products Because of Possible Health Risk
Summary Company Announcement Date: August 12, 2025 FDA Publish Date: August 12, 2025 Product Type: Food & Beverages Cheese/Cheese Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Listeria monocytogenes Company Name: Wegmans New York Brand Name: Brand Name(s) Product Description: Product Description Company Announcement Rochester, N.Y. – Wegmans Food Markets,…
Quesito El Establo Recalls Spanish Cheese (Quesito Colombiano) Because of Possible Health Risk
Summary Company Announcement Date: August 12, 2025 FDA Publish Date: August 12, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Due to the presence of rodent, rodent activity, and other insanitary conditions during the manufacturing and storage process Company Name: Quesito El Establo Brand Name: Brand Name(s) Quesito El…
Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) Readings
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 Name Model Number UDI-DI Lot Numbers Filter SafeStar 90 Plus MP05785 04048675665762 All lot…
Neuhaus Issues Allergy Alert on Undeclared Wheat in Belgian Chocolate Moments Smurf’s Popping Milk Chocolates with Cookies’
Summary Company Announcement Date: August 08, 2025 FDA Publish Date: August 10, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared wheat allergen Company Name: Neuhaus Chocolates NV Brand Name: Brand Name(s) Product Description: Product Description Belgian Chocolate Moments Smurfs Popping Milk Chocolates with Cookies Company Announcement Neuhaus Chocolates NV…
DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination
Summary Company Announcement Date: August 08, 2025 FDA Publish Date: August 09, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Contamination with Burkholderia cepacia Company Name: DermaRite Industries, LL Brand Name: Brand Name(s) DermaKleen, Dermasarra, Kleenfoam, and Perigiene Product Description: Product Description OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic…
Early Alert: WATCHMAN Access System Issue from Boston Scientific
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Boston Scientific has issued…
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live): FDA Safety Communication
AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics ISSUE: On May 9, 2025, FDA issued a safety communication informing the public that the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) jointly recommended a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals…