Smiths Medical Issues Worldwide Notification Regarding the Recall of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe With Skewed Graduation Markings

Summary Company Announcement Date: June 16, 2021 FDA Publish Date: June 17, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Skewed odd number line graduation markings on syringe barrels. Company Name: Smiths Medical Brand Name: Brand Name(s) Product Description: Product Description Hypodermic Needle-Pro Fixed Needle Insulin Syringes Company Announcement Smiths Medical has…

Philips Issues a Recall Notification* to Mitigate Potential Health Risks Related to the Sound Abatement Foam Component in Certain Sleep and Respiratory Care Devices

Summary Company Announcement Date: June 14, 2021 FDA Publish Date: June 15, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices Company Name: Philips Brand Name: Brand Name(s) Product Description: Product Description Philips Bi-Level Positive Airway Pressure…

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

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…

Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication

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…

Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results

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…

2021 Biologics Recalls

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…

Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) – Lot Number: NMDS210011

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…

Stop New Implants of the Medtronic HVAD System – Letter to Health Care Providers

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…