CDRH is issuing this Early Alert to notify the public 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. The FDA is aware that Abiomed has issued a letter to affected customers recommending all Automated Impella Controllers be removed from…
Frutas y Hortalizas del Sur S.A. Expands Recall to Include One Lot of Great Value Frozen Organic Triple Berry Blend Because of Potential Contamination with Escherichia coli O145:H28 (E. coli O145)
Summary Company Announcement Date: September 02, 2026 FDA Publish Date: September 03, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Possible E. Coli Contamination Company Name: Frutas y Hortalizas del Sur S.A. Brand Name: Brand Name(s) Great Value Product Description: Product Description Organic Triple Berry Blend Company Announcement September…
Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing BD ChloraPrep Applicators
The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The affected products have been updated. Recommendations for what to do with the devices below have not…
Breathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing Circuits
The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. The affected products and recommendations for what to do with the devices below have not changed. This recall involves removing devices from where they are used or sold. Affected Product The FDA is aware that Medline…
LMSI LLC/Kofinas Olive Oil Issues a Voluntary Recall of its Garlic Mediterranean Infused Extra Virgin Olive Oil for Using a Garlic Essential Oil Not Approved for Culinary Use
Summary Company Announcement Date: August 31, 2026 FDA Publish Date: August 31, 2026 Product Type: Food & Beverages Ingredients Reason for Announcement: Recall Reason Description Contains garlic essential oil not approved for culinary use Company Name: LMSI LLC Brand Name: Brand Name(s) Product Description: Product Description Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml,…
Ana Salazar Modela Tu Cuerpo Inc. Issues Nationwide Voluntary Recall of Lipofit Extreme Fat Burner 2.0 Due to Presence of Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
Summary Company Announcement Date: August 27, 2026 FDA Publish Date: August 31, 2026 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP) Company Name: Ana Salazar Modela Tu Cuerpo Inc. Brand Name: Brand Name(s) Product Description: Product Description Lipofit Extreme 2.0 Fat Burner Dietary Supplement Company Announcement FOR IMMEDIATE…
Crystal Temptations Issues Allergy Alert on Undeclared Milk in Chocolatey Eyeballs
Summary Company Announcement Date: August 31, 2026 FDA Publish Date: August 31, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Crystal Temptations Brand Name: Brand Name(s) Little Temptations Product Description: Product Description Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz. Company…
Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging
CDRH is issuing this Early Alert to notify the public 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. The FDA is aware that Medtronic and their subsidiary Given Imaging, Inc. have issued a letter to affected customers recommending…
B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter
Summary Company Announcement Date: August 27, 2026 FDA Publish Date: August 28, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter identified as iron oxide Company Name: B. Braun Medical Inc. Brand Name: Brand Name(s) Product Description: Product Description 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL…
Northwest Naturals Voluntarily Recalls Two Raw Pet Food Products Because of Possible Salmonella & Listeria Monocytogenes Health Risk
Summary Company Announcement Date: August 28, 2026 FDA Publish Date: August 28, 2026 Product Type: Animal & VeterinaryFood & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential contamination with Salmonella and/or Listeria monocytogenes Company Name: Northwest Naturals Brand Name: Brand Name(s) Northwest Naturals Product Description: Product Description Chicken Recipe Company Announcement Northwest Naturals…