Summary Company Announcement Date: March 17, 2026 FDA Publish Date: March 18, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared Wheat and Soy Company Name: Mama Grande Tortilla Factory Brand Name: Brand Name(s) Mama Grande Product Description: Product Description Gorditas de Azucar and Doraditas de Azucar Company Announcement Mama…
Early Alert: Insulin Pump Issue from Insulet
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 Insulet has issued a letter to affected customers recommending certain Omnipod 5 Pods be…
Dialysis Tubing Set Correction: Vantive Updates Use Instructions for Prismaflex and Oxiris Sets
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 updating instructions for affected devices, and does not involve removing them from where they are used or…
Convenience Kit Needle Recall: Integra LifeSciences Removes Tuohy Needle
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 certain devices from where they are used or sold. Affected Product The FDA is aware that…
Pure Vitamins and Natural Supplements, LLC Issues Voluntary Nationwide Recall of Honey Products Due to Undeclared Sildenafil and Tadalafil
Summary Company Announcement Date: March 14, 2026 FDA Publish Date: March 14, 2026 Product Type: Dietary SupplementsFood & Beverages Reason for Announcement: Recall Reason Description Product contains sildenafil and tadalafil Company Name: Pure Vitamins and Natural Supplements, LLC Brand Name: Brand Name(s) Boner Bear, Red Bull and Blue Bull Product Description: Product Description Honey dietary…
Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.
Summary Company Announcement Date: March 12, 2026 FDA Publish Date: March 13, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Pods may have a small tear in the internal tubing that delivers insulin. This may leak inside the Pod instead of being fully infused into the body as intended. Company Name: Insulet…
Lidl US Issues Allergy Alert on Undeclared Hazelnuts in Favorina Chocolate Ladybugs – German-Style Nougat
Summary Company Announcement Date: March 12, 2026 FDA Publish Date: March 12, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared hazelnut allergen Company Name: Lidl US Brand Name: Brand Name(s) Product Description: Product Description Chocolate Ladybugs – German-Style Nougat Candy Company Announcement ARLINGTON, VA – Lidl US is recalling…
Primal Herbs Issues Voluntary Nationwide Recall of Primal Herbs Volume Due to Undeclared Sildenafil
Summary Company Announcement Date: February 27, 2026 FDA Publish Date: March 11, 2026 Product Type: Dietary SupplementsFood & Beverages Reason for Announcement: Recall Reason Description Product contains sildenafil Company Name: Primal Supplements Group LLC Brand Name: Brand Name(s) Primal Herbs Product Description: Product Description Dietary supplement Company Announcement This recall is being conducted in coordination…
Early Alert: Flexible Cryoprobe Issue from Erbe USA
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 Erbe USA has issued a letter to affected customers recommending certain Erbe Flexible Cryprobes…
Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
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. This is an expansion of a previous recall. Affected Product The FDA is aware that Medline Industries…