Summary Company Announcement Date: November 04, 2024 FDA Publish Date: November 05, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Diclofenac Company Name: Boulla LLC Brand Name: Brand Name(s) Boulla LLC Product Description: Product Description Marketed as Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA,…
Savencia Cheese USA Announces Voluntary Recall of Select Soft Ripened Cheeses
Summary Company Announcement Date: November 02, 2024 FDA Publish Date: November 04, 2024 Product Type: Food & Beverages Cheese/Cheese Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Listeria monocytogens Company Name: Savencia Cheese USA Brand Name: Brand Name(s) Aldi, La Bonne Vie and others Product Description: Product Description Soft ripened…
HH Fresh Trading Corp Recalls Taiwan Enoki 200gx25pk Because of Possible Health Risk
Summary Company Announcement Date: November 01, 2024 FDA Publish Date: November 02, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes. Company Name: HH Fresh Trading Corp of California Brand Name: Brand Name(s) HH Fresh Trading Product Description: Product Description Enoki Mushrooms Company Announcement HH…
Spa Owner Arrested for Allegedly Performing Thousands of Illegal Counterfeit Injections on Clients for Over Three Years
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEFriday, November 1, 2024 Defendant owns Skin Beaute Med Spa in Randolph and South Easton BOSTON – A Stoughton woman has been arrested and charged in connection with smuggling goods into the United States and selling/dispensing counterfeit drugs and devices. Rebecca Fadanelli, 38, was charged by…
IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure
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 Names: Phasitron 5 breathing circuits Part Numbers/Lot Numbers: P5-10/240329, 240412,240430, 240509, 240516, 240614, 240625 …
Air Compressor Device Correction: GE HealthCare Provides Updates to EVair Compressors Due to Final Formaldehyde Testing Results
This recall involves updating recall instructions for using these 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…
Florida Company Pleads Guilty to Conspiring to Sell Misbranded N95 Masks to Hospital in Early Months of COVID-19 Pandemic
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEWednesday, October 30, 2024 Two individuals also pleaded guilty to misbranding N95 masks and conspiracy to commit price gouging BOSTON – A Florida company, and two individuals associated with the company, have pleaded guilty to charges associated with shipping facemasks that were misbranded as N95 respirators,…
Elevation Foods Issues Recall Due to Undeclared Soy in Hannaford Seafood Salad
Summary Company Announcement Date: October 31, 2024 FDA Publish Date: October 31, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Contains an undeclared soy allergen. Company Name: R. Walters LLC dba Elevation Foods Brand Name: Brand Name(s) Product Description: Product Description Seafood Salad Company Announcement Danvers, Massachusetts. R. Walters LLC…
Incubator/Warmer Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation due to Risk of Heater Door Falling and Causing Infant Injury
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Update: Use of GE HealthCare EVair and EVair 03 Compressors – Letter to Health Care Providers
October 29, 2024 The U.S. Food and Drug Administration (FDA) is issuing this update to inform the health care community of a change in recommendations for the GE HealthCare EVair Compressor. Previously, on December 29, 2023, GE HealthCare issued an Urgent Medical Device Correction notice to inform users about the potential for elevated levels of…