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 Philips Ultrasound has issued a letter to affected customers recommending all Lumify diagnostic ultrasound systems…
Krasnyi Oktyabr Inc. Recalls Starfish Seafood Trio Because of Possible Health Risk
Summary Company Announcement Date: October 09, 2026 FDA Publish Date: October 09, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: Krasnyi Oktyabr Inc. Brand Name: Brand Name(s) Starfish Seafood Product Description: Product Description Cold Smoked Salmon, Halibut, and Trout Company…
Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter
Summary Company Announcement Date: October 08, 2026 FDA Publish Date: October 09, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter identified as cellulose Company Name: Par Health Brand Name: Brand Name(s) Par Pharmaceutical Product Description: Product Description Brevital Sodium 500 mg/vial for Injection Company Announcement FOR IMMEDIATE RELEASE –…
Oliva LLC Issues Allergy Alert on Undeclared Sesame in Baba Ghanouj, Spicy Baba Ghanouj, and Hummus
Summary Company Announcement Date: October 09, 2026 FDA Publish Date: October 09, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared sesame allergen Company Name: Oliva LLC. Brand Name: Brand Name(s) Riad’s Oliva to Go Product Description: Product Description Baba Ghanouj, Spicy Baba Ghanouj, and Hummus Company Announcement Oliva LLC…
Gardeners Basics Recalls Waltham 29 Broccoli Sprouting Seeds Due to Possible Salmonella Contamination
Summary Company Announcement Date: October 08, 2026 FDA Publish Date: October 08, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Product may be contaminated with Salmonella Company Name: Gardeners Basics Brand Name: Brand Name(s) Gardeners Basics Product Description: Product Description Broccoli Sprouting Seeds Company Announcement October 8, 2026, Gardeners…
Eden Brothers Recalls Calabrese Broccoli Seeds Due to Possible Salmonella Contamination
Summary Company Announcement Date: October 07, 2026 FDA Publish Date: October 07, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Eden Brothers LLC Brand Name: Brand Name(s) EDEN BROTHERS Product Description: Product Description Broccoli Seeds – Calabrese Company Announcement Arden, NC…
Nova Biomedical® Announces Global Medical Device Correction for StatStrip® Glucose Hospital Meter
Summary Company Announcement Date: October 05, 2026 FDA Publish Date: October 06, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Software issue may cause a glucose result to be associated to the wrong patient Company Name: Nova Biomedical Brand Name: Brand Name(s) Nova Biomedical StatStrip Product Description: Product Description StatStrip Glucose Hospital…
Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets
The affected products and recommendations for what to do with the devices below have changed. 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…
Flowers Foods Issues Recall of Nature’s Own Hawaiian Bread Due to Undeclared Milk
Summary Company Announcement Date: October 02, 2026 FDA Publish Date: October 05, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk allergen Company Name: Flowers Foods, Inc. Brand Name: Brand Name(s) Nature’s Own Product Description: Product Description Nature’s Own Hawaiian Bread, 20oz single loaf and 40 oz 2-pack Company…
IV Tubing Set Correction: ICU Medical Updates Use Instructions for IV Tubing Sets
The affected products and recommendations for what to do with the devices below have changed. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. Affected Product The FDA is aware that ICU Medical has issued a customer communication recommending updated use instructions for certain IV…