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. The devices described in this recall notice are the same devices announced in the FDA safety communication Do Not Use Skippack Medical Lab SARS-CoV-2 COVID-19 Tests. Recalled Product Product Names:…

The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2023 Safety Communications Content current as of: 02/07/2023 Article source: http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications

Update – February 7, 2023: The Mammography Quality Standards Act (MQSA) certificate for Advanced Women Imaging, located at 6414 Bergenline Avenue, West New York, NJ (Bergenline) was revoked until January 4, 2025. The facility is currently unaccredited, uncertified, and cannot legally perform mammography. Additionally, the FDA has identified two individuals that qualify as owners or…

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 Name: CADD infusion system Administration Sets and Cassette Reservoirs  Product Models: See Medical Device Recall Database entries Distribution Dates: June 15, 2018 to present Devices Recalled…

Summary Company Announcement Date: February 02, 2023 FDA Publish Date: February 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential microbial contamination Company Name: Global Pharma Healthcare Brand Name: Brand Name(s) EzriCare & Delsam Pharma Product Description: Product Description Artificial Tears Lubricant Eye Drops Company Announcement Global Pharma Healthcare is voluntarily recalling…

Summary Company Announcement Date: January 31, 2023 FDA Publish Date: February 01, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Subpotency Company Name: IBSA Pharma Inc. Brand Name: Brand Name(s) Product Description: Product Description TIROSINT®-SOL (levothyroxine sodium) Company Announcement IBSA Pharma Inc. is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution…

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 Name: Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters (Mahurkar QPlus)  Product Models: See Medical Device Recall Database entry Distribution Dates: March 19, 2022…

Summary Company Announcement Date: January 27, 2023 FDA Publish Date: January 30, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to presence of benzene Company Name: Edgewell Personal Care Brand Name: Brand Name(s) Banana Boat Product Description: Product Description Hair & Scalp Spray SPF 30 Company Announcement In the news release dated…

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 Name: LifeSPARC System Product Model: LifeSPARC Controller, Model LS-1000 Distribution Dates: December 19, 2019 to November 17, 2022 Devices Recalled in the U.S.: 589 Date Initiated…

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 Name: Emergent RSDL (Reactive Skin Decontamination Lotion) Kits Product Batch Number: 23005060 Distribution Dates: October 4, 2022 to October 14, 2022 Devices Recalled in the U.S.:…