Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers

The affected products and recommendations for what to do with the devices below have not 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.  The…

Galil Importing Corp Recalls Lior Cinnamon Ground Seasoning Due to Elevated Lead Levels

Summary Company Announcement Date: September 24, 2026 FDA Publish Date: September 24, 2026 Product Type: Food & Beverages Contaminants Reason for Announcement: Recall Reason Description Potential to be contaminated with elevated levels of lead Company Name: Galil Importing Corp Brand Name: Brand Name(s) Product Description: Product Description Ground cinnamon Company Announcement Galil Importing Corp of…

Deano’s Pasta Issue Allergy Alert on Undeclared Lobster in Pear and Pecorino Triangoli Ravioli

Summary Company Announcement Date: September 24, 2026 FDA Publish Date: September 24, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared crustacean shellfish (lobster) allergen Company Name: Deano’s Pasta Brand Name: Brand Name(s) Deano’s Pasta Product Description: Product Description Company Announcement Deano’s Pasta of Somerville, MA is recalling approximately 20…

Early Alert: Ventilator Issue from React Health

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 Ventec Life Systems Inc., doing business as React Health, has issued a letter to affected…

Berlin Seeds Recalls Alfalfa Sprouting Seed Because of Possible Health Risk

Summary Company Announcement Date: September 23, 2026 FDA Publish Date: September 23, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) and/or Salmonella Company Name: Berlin Seeds Brand Name: Brand Name(s) Berlin Seeds Product Description: Product Description Alfalfa sprouting seeds…

Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter

Summary Company Announcement Date: September 18, 2026 FDA Publish Date: September 21, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter identified as cellulose or stopper material Company Name: Par Health Brand Name: Brand Name(s) Par Pharmaceutical Product Description: Product Description Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100…

Wakefern Food Corp. Voluntarily Recalls Wholesome Pantry Organic Unsweetened Apple Sauce

Summary Company Announcement Date: September 14, 2026 FDA Publish Date: September 22, 2026 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Elevated levels of patulin Company Name: Wakefern Food Corp. Brand Name: Brand Name(s) Wholesome Pantry Product Description: Product Description Organic Unsweetened Apple Sauce Company Announcement KEASBEY, N.J. (Sept. 14, 2026) –…

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection

Summary Company Announcement Date: September 17, 2026 FDA Publish Date: September 21, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection Company Name: Otsuka ICU Medical LLC Brand Name: Brand Name(s) ICU Medical LLC Product Description: Product Description…

Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets

The affected products and recommendations for what to do with the devices below have not 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. The…