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…
Risk of Invasive Disease in Preterm Infants Given Probiotics Formulated to Contain Live Bacteria or Yeast
AUDIENCE: Consumers, Patients, Health Professionals ISSUE: The U.S. Food and Drug Administration (FDA) is providing important safety information to healthcare providers on the use of products containing live bacteria or yeast (commonly called probiotics) in preterm infants in hospital settings. BACKGROUND: FDA has issued a Dear Healthcare Provider (DHCP) Letter to provide important safety information to healthcare providers…
Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Sinus, and Restore Sinus Spray Products Due to Microbial Contamination
Summary Company Announcement Date: September 29, 2023 FDA Publish Date: October 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Contamination with Microbacterium spp., Fictibacillus spp., Bacillus spp., and Paenibacillus spp. Company Name: Biomic Sciences Brand Name: Brand Name(s) Ion and Restore brands Product Description: Product Description Nasal Sprays Company Announcement ‘The…
Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray Products Due to Microbial Contamination
Summary Company Announcement Date: September 29, 2023 FDA Publish Date: October 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Contamination with Microbacterium spp., Fictibacillus spp., Bacillus spp., and Paenibacillus spp. Company Name: Biomic Sciences Brand Name: Brand Name(s) Ion and Restore brands Product Description: Product Description Nasal Sprays Company Announcement FOR…
Hospira, Inc. Issues a Voluntary Nationwide Recall for 4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl Injection, USP Due to the Potential for Presence of Glass Particulate Matter
Summary Company Announcement Date: October 02, 2023 FDA Publish Date: October 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Glass Particulates Company Name: Hospira, Inc. Brand Name: Brand Name(s) Product Description: Product Description 4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USP…
KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a Precautionary Measure Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged
Summary Company Announcement Date: September 29, 2023 FDA Publish Date: October 03, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Oxycodone HCl tablet Company Name: KVK-Tech, Inc. Brand Name: Brand Name(s) Product Description: Product Description Betaxolol Tablets, USP Company Announcement FOR IMMEDIATE RELEASE – 09/29/2023 – Newtown, Pennsylvania, KVK-Tech, Inc….