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 –…
Covetrus Sentenced for Criminal Misbranding of Prescription Drugs
Department of JusticeU.S. Attorney’s OfficeWestern District of Virginia FOR IMMEDIATE RELEASEThursday, May 9, 2024 Ohio-based Company Will Pay More Than $23 Million in Fines and Forfeiture ABINGDON, Va. – Covetrus North America LLC, a company based in Dublin, Ohio, which sells veterinary products to customers across the United States, was sentenced yesterday to one-year of probation…
Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band
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. Recalled Product Product Names: Product Codes: QJP, DQY, NRY Model Numbers: K190431 Route 92 Medical Delivery Catheter (DQY), also known as Tenzing 7 and sold separately. K203043 Route 92…
DaVinci Laboratories Issues Allergy Alert on Undeclared Shellfish Allergen in Amyloid Complete Product Lot 549853001
Summary Company Announcement Date: May 08, 2024 FDA Publish Date: May 09, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared shellfish (shrimp, crab) allergens Company Name: FoodScience, LLC Brand Name: Brand Name(s) FoodScience, LLC Product Description: Product Description Amyloid Complete dietary supplement capsules Company Announcement DaVinci Laboratories, a division…
Texas Pecan Issues Allergy Alert on Undeclared Tree Nuts (Not Named Individually), Soy, Dairy(Milk), Sesame and Wheat Not Named in Product
002 Almonds, Natural Whole 16oz 003 Almonds, Natural Whole 8oz 004 Almonds, Natural Sliced 16oz 005 Almonds, Natural Sliced 8oz 006 Almonds, Blanched Sliced 16oz 007 Almonds, Blanched Sliced 8oz 008 Almonds, Blanched Slivered 16oz 009 Almonds, Blanched Slivered 8oz 010 Almonds, Blanched Whole 16oz 012 Almonds, Natural Whole (R/S) 16oz 013 Almonds, Natural Whole…