Summary Company Announcement Date: June 11, 2021 FDA Publish Date: June 11, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains Nitrosodimethylamine (NDMA) impurities Company Name: Viona Pharmaceuticals Inc. Brand Name: Brand Name(s) Viona Pharmaceuticals Inc. Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets Company Announcement Viona Pharmaceuticals Inc., is voluntarily recalling 2…

Date Issued: June 10, 2021 The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, labeling distributed with…

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 Innova SARS-CoV-2 Antigen Rapid Qualitative Test (also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen…

June 2, 2021 Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) – Lot Number: NMDS210011 Product Numbers- VBM9901, VBM9905, VBM9910 and Lot Number- NMDS210011 Aziyo Biologics, Inc., (“Aziyo”) is the manufacturer of record for FiberCel Fiber Viable Bone Matrix (“FiberCel”) and is voluntarily recalling one Lot of the FiberCel product out of an abundance…

DATE NOTIFICATION INITIATED: June 2, 2021 PRODUCT / LOT NUMBER: FiberCel Fiber Viable Bone Matrix (“FiberCel”)Product Numbers: VBM9901, VBM9905, VBM9910Lot Number: NMDS210011 MANUFACTURER: Aziyo Biologics, Inc.Richmond, CA REASON: Aziyo Biologics, Inc., (“Aziyo”) is the manufacturer of record for FiberCel Fiber Viable Bone Matrix (“FiberCel”) and is voluntarily recalling one Lot of the FiberCel product, Donor…

June 3, 2021 The U.S. Food and Drug Administration (FDA) is alerting health care providers that Medtronic has stopped the sale and distribution of the Heartware Ventricular Assist Device (HVAD) System because: There is an increased risk of neurological adverse events and mortality associated with the internal pump. There is a potential for the internal…

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 Alaris Infusion Pump Module Model 8100 Bezel, purchased and/or installed by The Biomed Guys Models: Alaris Model 8100 Product Number: TIPA-8100-4410 Devices Recalled in the U.S.: 22…

Date Issued: May 28, 2021 The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography). The FDA has serious concerns about the performance of the SARS-CoV-2 Antigen Rapid Test Kit and…

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 Alaris Infusion Pump Module Model 8100 Bezel, purchased and/or installed by Step-Har Medical Models: Alaris Model 8100 Serial Numbers: 12747983 and 9919591 Devices Recalled in the U.S.:…

Summary Company Announcement Date: May 27, 2021 FDA Publish Date: May 28, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sibutramine and Fluoxetine Company Name: Dash Xclusive Brand Name: Brand Name(s) Imperia Elita Product Description: Product Description Imperia Elita Vitaccino Coffee Company Announcement Dash Xclusive is voluntarily recalling all lots of Imperia…