Early Alert: Diagnostic Ultrasound System Issue from Philips Ultrasound

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…

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…