Summary Company Announcement Date: March 19, 2026 FDA Publish Date: March 26, 2026 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Product contains sildenafil and tadalafil Company Name: Gear Isle Brand Name: Brand Name(s) Gold Lion, ilum Product Description: Product Description Company Announcement FOR IMMEDIATE RELEASE – March 19, 2026– West Sacramento,…
Cryoprobe Recall: Erbe USA Removes Flexible Cryoprobes
The affected products have been updated to remove a part number with no affected lots. The 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…
Heating Pad Recall: Navajo Manufacturing Company Removes Handy Solutions Neck & Shoulders Heating Pad
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 recall is an updated Early Alert. The affected products and recommendations for what to do with…
Cardinal Health Issues Voluntary Nationwide Recall of Webcol™ Large Alcohol Prep Pad
Summary Company Announcement Date: March 19, 2026 FDA Publish Date: March 20, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial Contamination Company Name: Cardinal Health Brand Name: Brand Name(s) Product Description: Product Description Large Alcohol Prep Pads (70% isopropyl alcohol) Company Announcement FOR IMMEDIATE RELEASE / DUBLIN, Ohio, March 19, 2026 –…
Early Alert: Handy Solutions Neck & Shoulders Heating Pad Issue from Navajo Manufacturing Company
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 Navajo Manufacturing Company has issued a letter to affected customers recommending affected heating pads…
Early Alert: Surgical Stapler Issue from Intuitive Surgical
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 Intuitive Surgical has issued a letter to affected customers recommending certain curved-tip staplers be…
Mama Grande Tortilla Factory Issues Allergy Alert on Undeclared Wheat and Soy in Gorditas de Azucar and Doraditas de Azucar
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…