English Actualización – 7 de febrero de 2023: El certificado de la Ley de estándares de calidad de mamografía (MQSA, por sus siglas en inglés) para Advanced Women Imaging (en inglés), en 6414 Bergenline Avenue, West New York, NJ (Bergenline) fue revocado hasta el 4 de enero de 2025. Actualmente, el centro no está acreditado…

Summary Company Announcement Date: February 13, 2023 FDA Publish Date: February 13, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared tadalafil and sildenafil Company Name: Volt Candy Brand Name: Brand Name(s) Product Description: Product Description PrimeZEN Black 6000 male enhancement capsules Company Announcement FOR IMMEDIATE RELEASE – 2/13/2023 – Pomona,…

Summary Company Announcement Date: February 09, 2023 FDA Publish Date: February 10, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Products were distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA. Company Name: Universal Meditech Inc. Brand…

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Act (MQSA) certificate for Advanced Women Imaging, located at 6414 Bergenline Avenue, West New York, NJ (Bergenline) was revoked until January 4, 2025.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…