Summary Company Announcement Date: September 20, 2024 FDA Publish Date: September 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Glass Particle Company Name: Gilead Sciences, Inc. Brand Name: Brand Name(s) Product Description: Product Description Veklury (remdesivir) for Injection Company Announcement FOR IMMEDIATE RELEASE – Foster City, Calif., September…
Do Not Use Medtronic NIM Standard and Contact EMG Endotracheal Tubes – Letter to Health Care Providers
July 9, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities to stop using NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes by Medtronic. These neural integrity monitor (NIM) electromyogram (EMG) endotracheal tubes are used during surgery to provide an airway for patient ventilation…
Ventilator Recall: Baxter Removes Life2000 Ventilator Due to Potential Failure of Battery Charging Dongle
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 Name: Life2000 Ventilator Unique Device Identifier (UDI): 00887761978089 What to Do Make sure there…
Aurobindo Pharma USA, Inc. on Behalf of AuroHealth, Issues Voluntary Nationwide Recall of one (1) Lot of Healthy Living Over the Counter (OTC) Migraine Relief: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg Tablets, Due to Missing Manufacturer Label
Summary Company Announcement Date: July 18, 2024 FDA Publish Date: July 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Mislabeling Company Name: Aurobindo Pharma USA, Inc. Brand Name: Brand Name(s) Healthy Living Product Description: Product Description Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets…
Endotracheal Tube Recall: Medline Industries, LP Removes Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to Detachment or Tearing of the Inflation Tube from the Main Tube
This recall involves removing 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: Medline Sub-G Endotracheal Tube with Subglottic Suctioning Unique Device Identifier (UDI)/Model: This recall includes…
Getinge Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride
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 Name: Vaporizer Sevoflurane Maquet Filling Product Code: 6682282 Distributed Serial Numbers: 17003 – 23454 Devices Recalled in the U.S.: 120 Dates Distributed: February 2, 2022 to…
Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits for Manufacturing Issue That May Prevent Full Balloon Inflation and Cause Patient Harm
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 Name: Arrow FiberOptix Intra-Aortic Balloon (IAB) Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter…
Electrode Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for Risk of Serious Burn Injuries to Patients
This recall involves removing 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 Figure 1: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode Product Name: MEGADYNE MEGA SOFT Pediatric Patient…
Suntegrity Skincare Issues Voluntary Recall of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) Due to Microbial Contamination
Summary Company Announcement Date: June 11, 2024 FDA Publish Date: June 12, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Higher than acceptable microbiological mold count Company Name: Suntegrity Skincare Brand Name: Brand Name(s) Suntegrity Product Description: Product Description Sunscreen foundation Company Announcement FOR IMMEDIATE RELEASE – Jun 11, 2024 – Las Vegas,…
Male Enhancement Supplements Recalled
Summary Company Announcement Date: February 01, 2024 FDA Publish Date: June 11, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Product is tainted with sildenafil and tadalafil Company Name: Integrity Products Brand Name: Brand Name(s) Ram It, To The Moon Product Description: Product Description Dietary Supplements for Male Sexual Enhancement Company Announcement…