The FDA has identified this recall as the most serious type.This recall involves: removing the Pipeline Vantage 027 device models from where they are used or sold updating instructions for using the Pipeline Vantage 021 device models Affected Product Product Names: Removal of unused: Pipeline Vantage Embolization Device with Shield Technology, 027 Compatible (Pipeline Vantage…
Disruptions in Availability of Hemodialysis Bloodlines – Letter to Health Care Providers
March 14, 2025 The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of hemodialysis bloodlines because of recent supplier issues. The disruption in supply of this device is expected to impact patient care and as such may require adjustments to the clinical management of patients receiving…
Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag
Summary Company Announcement Date: March 13, 2025 FDA Publish Date: March 13, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling of infusion bag Company Name: Dr. Reddy’s Laboratories Ltd. Brand Name: Brand Name(s) Dr. Reddy’s Product Description: Product Description Levetiracetam in Sodium Chloride Injection Company Announcement Dr. Reddy’s Laboratories Ltd. (BSE: 500124,…
Smiths Medical Issues Urgent Medical Device Correction Informing Customers of a Potential Issue with Certain Sizes of Intubation ORAL/NASAL Endotracheal Tubes Being Smaller Than Expected
Summary Company Announcement Date: March 07, 2025 FDA Publish Date: March 10, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Diameter of Device Smaller than Expected Company Name: Smiths Medical Brand Name: Brand Name(s) Product Description: Product Description Intubation Oral/Nasal Endotracheal Tubes Company Announcement MINNEAPOLIS, MN. March 7, 2025 – Smiths Medical…
Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals – Due to Increased Reports of Allergic/Hypersensitivity Reactions
AUDIENCE: Patient, Health Professional, Pharmacy, Immunology ISSUE: As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant. Product Lot Date of Voluntary Withdrawal Expiration Date …
Central Admixture Pharmacy Services (CAPS) Issues Nationwide Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags Due to Visible Black Particulate Matter in a Single-Sealed Vial
Summary Company Announcement Date: February 24, 2025 FDA Publish Date: February 25, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to visible black particulate matter Company Name: CAPS Brand Name: Brand Name(s) Product Description: Product Description Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag Company…
Natural Dior LLC Issues Voluntary Nationwide Recall of Vitafer-L Gold Liquid Due to Presence of Undeclared Tadalafil
Summary Company Announcement Date: February 25, 2025 FDA Publish Date: February 26, 2025 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Natural Dior LLC Brand Name: Brand Name(s) Natural Dior LLC Product Description: Product Description Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – Natural Dior LLC (USA) – February…
Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned Mattresses
This recall involves updating instructions for using 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. Affected Product …
Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient Ischemic Attack
This recall involves updating the 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. Affected Product…
Update on Alert: Solution Set Issue from Baxter Healthcare Corporation
This communication was initially issued as part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves removing certain devices from where they are used or sold. The affected products and recommendations…