Summary Company Announcement Date: May 17, 2024 FDA Publish Date: May 17, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Due to Unlabeled Wheat Allergen Company Name: Reser’s Fine Foods Brand Name: Brand Name(s) Product Description: Product Description Macaroni Salad Company Announcement Beaverton, OR May 17, 2024 Reser’s Fine Foods…
Sun Noodle Issues Allergy Alert on Undeclared Egg in S&S Frozen Cup Saimin
Summary Company Announcement Date: May 16, 2024 FDA Publish Date: May 17, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May contain undeclared egg white powder Company Name: Sun Noodle Brand Name: Brand Name(s) Product Description: Product Description Saimin Noodles with Soup & Garnishes Company Announcement [HONOLULU, HI, May 16th,…
Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Name: HeartMate 3 Left Ventricular Assist System Implant Kit Product Codes: See Recall…
Voluntary Recall of Select Great Value Organic Black Chia Seeds Due to The Possible Presence of Salmonella
Summary Company Announcement Date: May 10, 2024 FDA Publish Date: May 13, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Presence of Salmonella Company Name: Natural Sourcing International Brand Name: Brand Name(s) Great Value Product Description: Product Description Organic Chia Seeds Company Announcement FOR IMMEDIATE RELEASE – May…
Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction
Please be aware, this recall is a correction, not a product removal. Philips Respironics is providing a software update for its Trilogy Evo continuous ventilators. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices without the software update may cause serious injuries or death….
Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication
Date Issued: May 13, 2024 The U.S. Food and Drug Administration (FDA) is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests for Home and Over-the-Counter (OTC) Use and its COVID-19 Test intended for patient care settings due to increased risk of false results. Recommendations for Home Test…
Safety and Quality Concerns with Getinge Cardiovascular Devices – Letter to Health Care Providers
May 8, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet cardiovascular medical devices: Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and Getinge/Maquet Cardiohelp system and HLS Sets. The FDA recommends that health care facilities…
Western Mixers Produce & Nuts, Inc. Recalls Yogurt Covered Pretzels Because of Possible Health Risk
Summary Company Announcement Date: May 10, 2024 FDA Publish Date: May 10, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Western Mixers Produce and Nuts Brand Name: Brand Name(s) First Street, Gelson’s, bulk at Down Home Goods and Thorp Fruit Product…
Healthwest Minerals Inc. DBA Mt Capra Products Recalls Goat Milk Formula Recipe Kit and Warns Consumers Against the Use of Product as Infant Formula
Summary Company Announcement Date: May 10, 2024 FDA Publish Date: May 10, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Product does not provide sufficient nutrition when used as an infant formula Company Name: Healthwest Minerals, Inc. dba Mt. Capra Products Brand Name: Brand Name(s) Product Description: Product Description Goat Milk…
MEGADYNE™ Initiates Global Discontinuation and Voluntary Recall of MEGA SOFT™ Pediatric Patient Return Electrode
Summary Company Announcement Date: May 10, 2024 FDA Publish Date: May 10, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Reports of patient burn injuries Company Name: Megadyne Medical Products Inc. Brand Name: Brand Name(s) Ethicon Megadyne Product Description: Product Description Mega Soft Pediatric Patient Return Electrode Company Announcement Cincinnati, OH –…