Summary Company Announcement Date: June 25, 2025 FDA Publish Date: June 25, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared pecans Company Name: Kilwins Quality Confections, LLC Brand Name: Brand Name(s) Product Description: Product Description Mocha Truffles Company Announcement Kilwins Quality Confections, LLC., of Petoskey, Michigan, is voluntarily recalling…
Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Procedure Kits Containing Medtronic Aortic Root Cannula due to Potential Excess Material in Male Luers
This recall involves correcting certain devices and does not involve removing them 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 without correction. Affected Product Product Names: Medline Kits Containing Medtronic…
Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers
June 24, 2025 The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries. Despite extensive and ongoing efforts to address compliance issues, FDA continues to have concerns related to outstanding Quality System regulation violations…
Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation
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 What to Do On May 15, 2025, Cook sent all affected customers a letter recommending…
Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware 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 Medtronic and their subsidiary…
Anesthesia Delivery Systems Recall: GE HealthCare Issues Correction for Certain Carestations due to Risk of Ineffective Ventilation When Used in Volume Control Ventilation (VCV) Mode
This recall involves correcting certain devices and does not involve removing them 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 without correction. Affected Product • Product Names: Carestation 620/650/650c and 750/750c Anesthesia…
Face Rock Creamery Voluntarily Recalls Vampire Slayer Garlic Cheddar Curds Because of Possible Health Risk
Summary Company Announcement Date: June 20, 2025 FDA Publish Date: June 21, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Listeria monocytogenes Company Name: Face Rock Creamer Brand Name: Brand Name(s) Face Rock Creamery Product Description: Product Description Vampire Slayer Garlic Cheddar Curds Company Announcement…
International Foodsource, LLC. Issues Allergy Alert in Nonpareil, Semi-Sweet Chocolate (Christmas Seeds) Sold as Dark Chocolate Nonpareils
Summary Company Announcement Date: June 20, 2025 FDA Publish Date: June 20, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description SE Grocers Company Name: Undeclared milk allergen Brand Name: Brand Name(s) SE Grocers Product Description: Product Description Dark chocolate nonpareils Company Announcement International Foodsource, LLC of Randolph NJ is recalling…
Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication – FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch
AUDIENCE: Patient, Health Care Professional, Neurology ISSUE: The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children 17 years and younger and in adults 60 years and older, who may…
Sabores Bakery, Dba Sabores A Tu Mesa, Issues Allergy Alert on Undeclared Milk in Mousse Desserts
Summary Company Announcement Date: June 20, 2025 FDA Publish Date: June 20, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk allergen Company Name: Sabores Fit Bakery Brand Name: Brand Name(s) Sabores A Tu Mesa Product Description: Product Description Mousse Desserts Company Announcement Sabores Fit Bakery of Kissimmee, FL…