This recall involves updating instructions for using 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 Product…
Sprout Organics Expands Voluntary Recall of Sweet Potato Apple and Spinach to Include Additional Lot Codes
Summary Company Announcement Date: September 23, 2025 FDA Publish Date: September 23, 2025 Product Type: Food & Beverages Contaminants Reason for Announcement: Recall Reason Description Potential Metal Contaminant – 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 Sprout Organics…
Lawrence Wholesale LLC Recalls Kroger Bagged Frozen Shrimp and Kroger Frozen Shrimp Products Because of Possible Health Risk
Summary Company Announcement Date: September 23, 2025 FDA Publish Date: September 23, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Due to possible radionuclide (Cesium-137) contamination. Company Name: LAWRENCE WHOLESALE LLC Brand Name: Brand Name(s) Product Description: Product Description Frozen shrimp Company Announcement Lawrence Wholesale LLC of Vernon, CA…
Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips
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: ViziShot 2 FLEX (19G) Unique Device Identifier (UDI): 00821925043060 Lot Numbers: Full list…
Lee K of NY Issue Allergy Alert on Undeclared Allergen (Milk and Shrimp) in “Stewed Aged Kimchi w/Mackerel”
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…