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: Impella 5.5 with SmartAssist Product Code: 0550-0008 Product Serial Numbers: See Recall Database Entry Distribution Dates: September 28, 2021 to March 6, 2023 Devices Recalled…

June 5, 2023 The U.S. Food and Drug Administration (FDA) is aware of health care facilities and providers experiencing localized supply constraints of non-sterile, single-use pneumatic tourniquet cuffs in the United States. These devices are mainly used in elective limb surgeries and in emergency and trauma settings. During interruption in the supply of these devices,…

English Fecha de publicación: 10 de mayo de 2023 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está proporcionando otra actualización sobre el sistema de dispositivos Renuvion/J-Plasma de Apyx Medical con respecto al uso del dispositivo para ciertos procedimientos estéticos de la piel y una autorización adicional…

[Posted 05/26/2023]  AUDIENCE: Patient, Health Professional, Pharmacy, Psychiatry, Pediatrics   ISSUE: The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines. The current prescribing information for some prescription stimulants does not provide up to date warnings about the harms 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 Product Names: Pilot COVID-19 At-Home Tests Product Codes: See Safety Communication Distribution Dates: August 2022 to March 2023 Devices Recalled in the U.S.: 2,712,767 U.S. Government:…

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: Seattle PAP Plus, VentStar Basic (P)180, VentStar Basic(P)250, VentStar Watertrap (P) 180, VentStar Watertrap (P) 180 w/oLL, VentStar Anesthesia WT (P)180, VentStar breathing bag Set…

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: Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Battery List Numbers: Plum 360: SUB0000864 Plum A+ and Plum A+3: SUB0000594 Devices…

Summary Company Announcement Date: May 18, 2023 FDA Publish Date: May 19, 2023 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Packaging may contain incorrect product Company Name: NOVIS PR LLC Brand Name: Brand Name(s) G-SUPRESS DX Product Description: Product Description Cough Suppressant, expectorant, nasal decongestant pediatric drops Company Announcement 15/05/23– San…

Summary Company Announcement Date: May 18, 2023 FDA Publish Date: May 19, 2023 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety/Mislabeling Company Name: NOVIS PR LLC Brand Name: Brand Name(s) G-SUPRESS DX Product Description: Product Description Cough Suppressant, expectorant, nasal decongestant pediatric drops Company Announcement  05/15/23– San Juan,…

Summary Company Announcement Date: May 10, 2023 FDA Publish Date: May 12, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for injuries, including skin burns & irritation Company Name: BearCare, Inc Brand Name: Brand Name(s) Product Description: Product Description Wearable Smart Thermometer Company Announcement Hauppauge, NY, May 10, 2023– BearCare, Inc….