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. Affected Product The FDA is aware that ICU Medical has issued a customer communication recommending certain IV tubing sets be removed…
Bazzini Voluntarily Recalls Certain Lots of SkinnyDipped® Dark Chocolate Coconut Almond Bites Due to Undeclared Peanut Allergen
Summary Company Announcement Date: May 27, 2026 FDA Publish Date: May 27, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May Contain undeclared peanuts Company Name: Bazzini, LLC Brand Name: Brand Name(s) SkinnyDipped Product Description: Product Description Dark Chocolate Coconut Almond Bites Company Announcement Bazzini, LLC, of Allentown, PA, a…
Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® Pods in the U.S. and Affected International Markets
Summary Company Announcement Date: May 26, 2026 FDA Publish Date: May 26, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Manufacturing issue that could result in under delivery of insulin Company Name: Insulet Corporation, Inc. Brand Name: Brand Name(s) Product Description: Product Description Device intended for the subcutaneous delivery of insulin into…
Total Nutrition Inc. Recalls TNVitamins and Doctor’s Pride Ultra Potent Complete Green Superfood Moringa Capsules Because of Possible Health Risk
Summary Company Announcement Date: May 26, 2026 FDA Publish Date: May 26, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Possible Salmonella Contamination Company Name: Total Nutrition Inc. Brand Name: Brand Name(s) TNVitamins and Doctor’s Pride Product Description: Product Description TNVitamins Ultra Potent Complete Green Superfood Capsules and Doctor’s…
Mogo Moringa LLC Announces Voluntary Recall of Select Lots of Moringa Capsules Due to Possible Salmonella Contamination
Summary Company Announcement Date: May 25, 2026 FDA Publish Date: May 26, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Possible Salmonella Contamination Company Name: Mogo Moringa LLC Brand Name: Brand Name(s) Product Description: Product Description Mogo Moringa Oleifera Capsules Company Announcement FOR IMMEDIATE RELEASE Mogo Moringa LLC Announces…
Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators
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 The FDA is aware that Ventec, doing business as React Health, has issued a…
SKS Copack Recalls Various Specialty Beverages Because of Possible Health Risk
Summary Company Announcement Date: May 22, 2026 FDA Publish Date: May 23, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Due to contamination of Salmonella Company Name: SKS Copack Brand Name: Brand Name(s) Angel Specialty Products, Royal Gold, Boba Time, Fanale, Denda Product Description: Product Description Specialty Beverages Company…
JXK Enterprises, Inc Issues Voluntary Nationwide Recall of Boner Bears Chocolate Due to Undeclared Sildenafil
Summary Company Announcement Date: May 21, 2026 FDA Publish Date: May 23, 2026 Product Type: Food & Beverages Ingredients Reason for Announcement: Recall Reason Description Product contains sildenafil Company Name: JXK Enterprises, Inc Brand Name: Brand Name(s) Boner Bears Product Description: Product Description Company Announcement JXK Enterprises, Inc is voluntarily recalling Boner Bears Chocolate, Lot…
Raaw Energy Expands Recall of Dog Food Because of Listeria Monocytogenes Health Risk
4411 (Beef, Tripe, Duck Necks, and Chicken) 5-lb tubes 9.9.2025, 9.23.2025, 10.14.2025, 10.15.2025 4411(Beef, Tripe, Duck Necks, and Chicken) 2-lb tubes 9.9.2025, 9.23.2025, 10.15.2025 60/30/10 Chicken Medley 5-lb tubes 10.10.2025 60/30/10 Chicken Medley 2-lb tubes 7.29.2025, 8.6.2025, 8.7.2025 60/30/10 Turkey Medley 5-lb tubes 7.24.2025, 7.29.2025 60/30/10 Turkey Medley 2-lb tubes 7.24.2025, 7.29.2025 70/30/Beef Heart 5-lb…
Automated Compounding System Recall: Omnicell Removes Syringe Labels Used with the i.v.STATION Automated Compounding System
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 affected products and recommendations for what to do with the devices below have not changed. Affected…