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. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: Cardinal Health Monoject single use Luer lock syringes 1, 6, 12, 20,…
Covidien LLC Recalls McGRATH MAC Video Laryngoscope Due to Stolen Defective Products
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 (Include the following information) Product Names: McGRATH™ MAC Video Laryngoscopes Product Codes: See Recall Database Entry Item Code: 301-000-000 Distribution Dates: July 5, 2019 to July 14,…
Labeling Updates for BD Mesh Products – Letter to Health Care Providers
November 9, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about labeling updates for Becton, Dickinson and Company (BD) mesh products: Phasix Mesh Phasix ST Mesh Phasix Plug and Patch Phasix ST Mesh with Open Positioning System (OPS) Phasix ST Mesh with Echo 2 Positioning System, and GalaFLEX Lite Scaffold…
Do Not Use Certain Brands of Saline and Sterile Water Medical Products by Nurse Assist Because They May Not Be Sterile: FDA Safety Communication
Date Issued: November 6, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers, health care providers, and health care facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands. On November 6, 2023, Nurse Assist, LLC announced a recall…
Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada
Summary Company Announcement Date: November 06, 2023 FDA Publish Date: November 06, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Lack of sterility assurance Company Name: Nurse Assist, LLC Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Company…
Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling
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 Names: Pressure Injectable Central Venous Catheters Product Codes: See table below Distribution Dates: August 30, 2022 to June 9, 2023 Devices Recalled in the U.S.: 1,905…
The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections
Summary Company Announcement Date: October 31, 2023 FDA Publish Date: November 01, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Insanitary manufacturing conditions Company Name: The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories Brand Name: Brand Name(s) Product Description: Product Description OTC Ophthalmic Sterile Drops Company Announcement FOR IMMEDIATE RELEASE…
Cardinal Health, Inc. Issues Voluntary Nationwide Recall of Certain LEADER™ Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections
Summary Company Announcement Date: October 31, 2023 FDA Publish Date: November 01, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Insanitary manufacturing conditions Company Name: Cardinal Health, Inc. Brand Name: Brand Name(s) Product Description: Product Description OTC Ophthalmic Sterile Drops Company Announcement FOR IMMEDIATE RELEASE – October 31, 2023 – Dublin, OH, Cardinal…
Olympus Recalls Olympus High Flow Insufflation Unit Due to Over-Inflation
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. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: Olympus High Flow Insufflation Unit Product Codes: See Recall Database Entry Model Numbers:…
Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL, Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL, and ELCYS (cysteine hydrochloride Injection), USP 500 mg/10 mL Due to the Presence of Particulate Matter
Summary Company Announcement Date: October 25, 2023 FDA Publish Date: October 25, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of particulate matter Company Name: Exela Pharma Sciences, LLC Brand Name: Brand Name(s) Exela and Civica Brands Product Description: Product Description Sodium Bicarbonate Injection, USP, Midazolam in 0.8% Sodium Chloride Injection…