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…
Fresenius Medical Care Recalls Some Hemodialysis Machines for Potential Exposure to Toxic Compounds
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: 2008 Series Hemodialysis Machines Product Codes and Model Numbers: Distribution Dates: August 21, 2008 to June 6, 2022 Devices Recalled in the U.S.: 207 Date…
Medtronic Notification of Stolen Defective Products – Potentially Defective McGRATH™ MAC Video Laryngoscopes
Summary Company Announcement Date: September 28, 2023 FDA Publish Date: October 19, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Stolen Potentially Defective Company Name: Medtronic Brand Name: Brand Name(s) Product Description: Product Description McGRATH MAC video laryngoscopes Company Announcement NOTE: McGRATH™ MAC video laryngoscopes purchased directly from Medtronic or via its…
Philips Respironics Recalls V60 and V60 Plus Ventilators due to Power Management Printed Circuit Board Assemblies (PM PCBAs) Not Meeting Ventilator Standards
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 voluntary correction, not a product removal. Recalled Product Product Names: Philips Respironics V60 Ventilators and V60 Plus Ventilators Product Codes: See Recall…
Hamilton Medical Inc. Recalls HAMILTON-C1, T1, MR-1 Ventilators for Capacitator Leaks and Short Circuits
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 voluntary correction, not a product removal. Recalled Product Product Names: Hamilton C1/T1/MR-1 Ventilators Product Codes: See Recall Database Entry Model Numbers: Hamilton-C1,…
Voluntary Recall of Certain Over-the-Counter Drugs and Medical Devices
Summary Company Announcement Date: October 05, 2023 FDA Publish Date: October 10, 2023 Product Type: DrugsMedical Devices Reason for Announcement: Recall Reason Description Products were stored outside of labeled temperature requirements Company Name: Family Dollar Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Over-the-Counter Drug and Medical Device products Company Announcement Family Dollar…