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 Products Product Names: MEGA Ballast Distal Access Platform (originally cleared as Next Generation Access Platform) Model…
MAMTAKIM Inc Recalls Dried Whole Smelts Salted (KORUSHKA) Because of Possible Health Risk
Summary Company Announcement Date: November 25, 2025 FDA Publish Date: November 25, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Clostridium botulinum. Company Name: Mamtakim, Inc. Brand Name: Brand Name(s) Product Description: Product Description Dried Whole Salted Smelt, Mullet, Goby Company Announcement MAMTAKIM Inc,…
Recall Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices
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 Product Name: SpeedControl Dial used with SmartDrive MX2+ Power Assist Device Part Numbers: MX2-3DCK, MX2-3DC,…
Early Alert: Large Volume Pump Primary Administration Set Reverse Flow Issue from Fresenius Kabi
This Early Alert communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk 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 Fresenius Kabi has…
Supreme Deli LLC Voluntarily Recalls Boar’s Head Pecorino Romano Cheese Because of Possible Health Risk
Summary Company Announcement Date: November 24, 2025 FDA Publish Date: November 24, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Due to the potential presence of Listeria monocytogenes Company Name: Supreme Service Solutions, LLC. Brand Name: Brand Name(s) Boar’s Head Product Description: Product Description Chicken Caesar Salad and Wrap Company Announcement…
Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits
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 LRO – Sterile Medline Convenience Kits: MAJOR PACK L-F, Model Number: DYNJ0382730O LB BASIC CUSTOM…
Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Rapid Command Input Issue
This recall involves correcting 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: NOxBOXi Nitric Oxide Delivery System Unique…
Recall Alert: Intersurgical Inc Removes i-View Video Laryngoscope
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 Product Name: i-View Video Laryngoscope Model Number: 8008000 Lot/Serial Numbers: 1240555 and 1240793 What to…
Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles
This recall involves updating instructions for using 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 following the updated instructions. Affected Products This…
PRIME FOOD PROCESSING LLC ISSUES ALLERGY ALERT ON UNDECLARED (MILK) IN LAVA BUN W/ SALTED EGG YOLK AND LAVA BUN WITH GREEN TEA FLAVOR
Summary Company Announcement Date: November 20, 2025 FDA Publish Date: November 20, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk allergen Company Name: Prime Food Processing LLC Brand Name: Brand Name(s) Prime Food Product Description: Product Description Company Announcement Prime Food Processing LLC of Brooklyn, NY is voluntarily…