This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves updating the Instructions for using these 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…
Infusion Pump Software Correction: Becton, Dickinson and Company (BD) Issues Correction for BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software Due to Risk for Outdated Automated Programming Requests to Load
This recall involves correcting software for 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 (Include the following information) Product Names:…
Early Alert: Aspiration System Issue from Calyxo
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 Calyxo has issued a…
Dessert Holdings Issues Allergy Alert on Undeclared Tree Nut Allergen in Favorite Day™ Gourmet New York Style Cheesecake 6oz/2ct
Summary Company Announcement Date: March 19, 2025 FDA Publish Date: March 20, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen – Pecans Company Name: Dessert Holdings Brand Name: Brand Name(s) Product Description: Product Description Favorite Day Gourmet New York Style Cheesecake Company Announcement KENNESAW, GA –…
Update on Alert: Infusion Pump Issue from Baxter Healthcare Corporation
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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…
Nestlé USA Announces Voluntary Recall of a Limited Quantity of Lean Cuisine® and STOUFFER’S® Frozen Meals Due to Potential Presence of Foreign Material
Summary Company Announcement Date: March 17, 2025 FDA Publish Date: March 18, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential Contaminant – Wood Company Name: Nestle USA Brand Name: Brand Name(s) Stouffer’s Product Description: Product Description Frozen meals Company Announcement ARLINGTON, VA., March 17, 2025 — Nestlé USA is initiating…
Embolization Device Recall and Correction: Medtronic Removes Unused 027 Compatible Pipeline Vantage Embolization Device with Shield Technology, Updates Use Instructions for 021 Compatible Pipeline Vantage Embolization Devices due to Increased Risk of Incomplete Wall Apposition and Braid Deformation
The FDA has identified this recall as the most serious type.This recall involves: removing the Pipeline Vantage 027 device models from where they are used or sold updating instructions for using the Pipeline Vantage 021 device models Affected Product Product Names: Removal of unused: Pipeline Vantage Embolization Device with Shield Technology, 027 Compatible (Pipeline Vantage…
Seabear Company Recalls Smoked Salmon Chowder and Alehouse Clam Chowder Because of Possible Health Risk
Summary Company Announcement Date: March 15, 2025 FDA Publish Date: March 15, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential contamination with Clostridium botulinum Company Name: Seabear Company Brand Name: Brand Name(s) Product Description: Product Description Alehouse Clam Chowder and Smoked Salmon Chowder Company Announcement SeaBear Company of Anacortes, Washington…
Disruptions in Availability of Hemodialysis Bloodlines – Letter to Health Care Providers
March 14, 2025 The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of hemodialysis bloodlines because of recent supplier issues. The disruption in supply of this device is expected to impact patient care and as such may require adjustments to the clinical management of patients receiving…
C.H. Guenther & Son LLC Issues Allergy Alert on Undeclared Egg in “365 Whole Foods Market Small Bites Macaroni & Cheese”
Summary Company Announcement Date: March 14, 2025 FDA Publish Date: March 14, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared eggs Company Name: C.H. Guenther & Son LLC Brand Name: Brand Name(s) 365 Whole Foods Market Product Description: Product Description Small Bites Macaroni & Cheese Company Announcement C.H. Guenther &…