This recall does not involve removing all products. Users should contact Medtronic if they experience significant reduced battery life to determine if a new pump is needed. The FDA has identified this recall as the most serious type. Affected Product Product Names: MiniMed 630G, 670G, 770G, 780G Model: See full list of affected devices. Lot/Serial…
Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life
Summary Company Announcement Date: October 04, 2024 FDA Publish Date: October 18, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device & Drug Safety – Defect Company Name: Medtronic plc Brand Name: Brand Name(s) Product Description: Product Description MiniMed™ 600 series or 700 series insulin pumps Company Announcement Customers are being notified…
Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding
This recall involves updating 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. UPDATE – Friday,…
Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles
Summary Company Announcement Date: October 10, 2024 FDA Publish Date: October 16, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Presence of glass particulates Company Name: STASKA Pharmaceuticals Inc. Brand Name: Brand Name(s) STASKA Pharmaceuticals Product Description: Product Description Ascorbic Acid Solution for Injection Company Announcement FOR IMMEDIATE…
UPDATE: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication
Español 简体中文 (Simplified Chinese) Tagalog Update: October 16, 2024 The FDA has classified Cue Health’s recall of their two COVID-19 tests as Class II. FDA has also revoked the Emergency Use Authorization (EUA) for Cue Health’s two COVID-19 tests. Additional information is provided in FDA Actions. Date Issued: May 13, 2024 The U.S. Food and Drug Administration…
C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug Ingredients: Diclofenac, Dexamethasone, and Methocarbamol
Summary Company Announcement Date: October 08, 2024 FDA Publish Date: October 16, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Unapproved Drug Company Name: C&A Naturistics Brand Name: Brand Name(s) Product Description: Product Description AK Forte Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 10/8/24 – National City,…
Infusion Pump Recall: Zyno Medical Removes Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients
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 Pump Model Unique Device Identifier (UDI-DI) Software Revision Z-800 00814377102006 6.1.01 and 6.1.07z Z-800W 00814371020020…
FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. Stop Medicine if Signs and Symptoms of Liver Injury Occur – Drug Safety Communication
[Posted 9/12/2024] AUDIENCE: Patient, Health Professional, OBGYN, Endocrinology ISSUE: The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury and potentially return liver function to normal….
Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets
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: Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25) Unique…
Philips Respironics Issues Additional Usage Instructions for Trilogy Evo Ventilators Related to Use of In-Line Nebulizers
Summary Company Announcement Date: October 07, 2024 FDA Publish Date: October 07, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description The use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow…