Summary Company Announcement Date: September 20, 2025 FDA Publish Date: September 20, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Product has the potential to be contaminated with Listeria monocytogenes Company Name: Western United Fish Company dba Annasea Foods Group Brand Name: Brand Name(s) Kirkland Signature Product Description: Product…
FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025
AUDIENCE: Consumer, Health Care Professional, Pediatrics, Family Practice, Neurology ISSUE: The FDA is warning retailers and consumers not to sell or use certain imported cookware that may leach significant levels of lead (Pb) into food. Some types of imported cookware products made from aluminum, brass, and aluminum alloys known as Hindalium/Hindolium or Indalium/Indolium have been…
Early Alert: TactiFlex Ablation Catheter Issue from Abbott
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 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 Abbott has issued a letter…
Do Not Use Unauthorized Devices for Measuring Blood Pressure: FDA Safety Communication
Date Issued: September 16, 2025 The U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using unauthorized devices that claim to measure or estimate blood pressure. Many blood pressure devices currently sold over-the-counter (OTC) do not have FDA marketing authorization, meaning the FDA has not…
Haifa Smoked Fish Recalls “Cold Smoked Salmon” and “Cold Smoked Seabass” Due to Possible Health Risk
Summary Company Announcement Date: September 16, 2025 FDA Publish Date: September 17, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential contamination with Listeria monocytogenes Company Name: Haifa Smoked Fish Brand Name: Brand Name(s) Product Description: Product Description Cold Smoked Salmon and Cold Smoked Seabass Company Announcement HAIFA SMOKED…
Early Alert: Medline Kits May Contain Recalled Medtronic Cardiac Cannulas
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 Medline has issued a…
Sprout Organics Voluntarily Recalls One Lot of Sweet Potato Apple and Spinach Due to Possible Health Risk
Summary Company Announcement Date: September 16, 2025 FDA Publish Date: September 16, 2025 Product Type: Food & Beverages Contaminants Reason for Announcement: Recall Reason Description Product may contain elevated levels of lead Company Name: Sprout Organics Brand Name: Brand Name(s) Sprout Organics Product Description: Product Description Sweet Potato Apple and Spinach, 3.5-ounce pouch Company Announcement…
Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error
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: Micro Joystick R-net Multi…
BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets
Summary Company Announcement Date: September 12, 2025 FDA Publish Date: September 15, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Pump performance variations compared to the performance described in the user manual could impact infusion delivery Company Name: BD Brand Name: Brand Name(s) Product Description: Product Description BD Alaris Pump Module model…
Update on Alert: Defibrillation Lead Issue from Boston Scientific
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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…