Summary Company Announcement Date: September 08, 2025 FDA Publish Date: September 23, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen – Milk and Shrimp Company Name: Lee K of NY INC Brand Name: Brand Name(s) Product Description: Product Description Stewed Aged Kimchi w/ Mackerel Company Announcement…
Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed
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 Abiomed has issued a letter…
Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker Wiring That May Cause Malfunction and Stop Insulin Delivery
Catalog Catalog# Description UDI-DI 1000911 t:slim X2 GS, Replacement, Refurbished 00853052007318 1003808 t:slim X2 GS Classic, Replacement, Refurbished 00853052007981 1004219 t:slim X2, Basal-IQ, mg/dl 00853052007998 1004484 Pump, t:slim X2, Clinical Use Only N/A 1005611 Pump, t:slim X2, Control-IQ, mmol/L 00850006613304 1005613 Pump, t:slim X2, Control-IQ, mmol/L, Refurbished Replacement 00850006613311 1005615 Pump, t:slim X2, Control-IQ, mg/dl…
Aquastar (USA) Corp Recalls Kroger Frozen Raw EZ Peel, Kroger Mercado Frozen Cooked Shrimp, and Aquastar Raw Shrimp Skewers Because of Possible Health Risk
Summary Company Announcement Date: September 20, 2025 FDA Publish Date: September 21, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Due to possible radionuclide (Cesium-137) contamination Company Name: Aquastar Corp Brand Name: Brand Name(s) Kroger, Kroger Mercado, AquaStar Product Description: Product Description Raw Shrimp, Cooked Shrimp, Shrimp Skewers Company…
Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication
Date Issued: September 16, 2025 The U.S. Food and Drug Administration (FDA) is warning consumers, caregivers, and health care providers of risks related to using unauthorized infant monitors for measuring and monitoring vital signs (such as heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature). Many infant monitors currently sold over-the-counter…
Western United Fish Company Recalls Kirkland Signature Brand Ahi Tuna Wasabi Poke Because of Possible Health Risk
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…