Date Issued: 11/12/2021 The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication on Philips Respironics recalled ventilators, BiPAP, and CPAP machines. This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. At this time, the FDA is not changing the recommendations from…

The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue FDA Safety Communication on October 5, 2021. The FDA has identified this as a Class I recall, the most serious type of…

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: Custom Convenience Kits containing the Cardinal Health Monoject Flush Prefilled Syringe including: Leaderflex Insertion Kit with Ultrasound, Insertion Tray-RX, Universal Procedure…

[Posted 11/02/2021]  AUDIENCE: Consumer, Health Professional, Pharmacy, Pediatrics, Caregivers     ISSUE: The FDA is warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye. Eye exposure to hand sanitizer has been…

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  ROSA One 3.1 Brain Application Product Codes and Lot Numbers: See Recall Database Entry  Devices Recalled in the United States: 119 Distribution Date: December 1, 2019 to…

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  Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Product Codes and Lot Numbers: See Recall Database Entry  Devices Recalled in the United States: 137 battery packs Distribution Date:…

Summary Company Announcement Date: October 26, 2021 FDA Publish Date: October 27, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Impurities Company Name: artnaturals Brand Name: Brand Name(s) artnaturals Product Description: Product Description Scent Free Hand Sanitizer Company Announcement artnaturals is voluntarily recalling ten manufacturing lots of artnaturals 8oz…

Summary Company Announcement Date: October 20, 2021 FDA Publish Date: October 27, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for the plunger to draw back after the air has been expelled and reintroduced air back into the syringe Company Name: Windstone Medical Packaging dba Aligned Medical Solutions Brand Name: Brand…

Summary Company Announcement Date: October 18, 2021 FDA Publish Date: October 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Bottles labeled as Methocarbamol 500mg tablets were found to contain Methocarbamol 750mg tablets. Company Name: Bryant Ranch Prepack Brand Name: Brand Name(s) Bryant Ranch Prepack Product Description: Product Description Methocarbamol 500mg Company Announcement…

Summary Company Announcement Date: October 19, 2021 FDA Publish Date: October 20, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains particulate matter identified as glass Company Name: Merck Brand Name: Brand Name(s) Product Description: Product Description Daptomycin for injection 500mg Company Announcement KENILWORTH, N.J., Oct. 19, 2021 – Merck (NYSE: MRK),…