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:…
Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support
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…
ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery
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…
Novis PR LLC Emite Retiro Voluntario de Gotas Pediátricas G-Supress DX Debido a Empaque Incorrecto
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…
Novis PR LLC Issues Voluntary Recall of G-Supress DX Pediatric Drops Due to Incorrect Packaging
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,…
BearCare Voluntarily Recalls Rechargeable Walnut Thermometer Due to the Potential for Skin Burns
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….
Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication
Date Issued: May 4, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid…
Family Dollar is Initiating a Voluntary Recall of Certain Over-the-Counter Drug Products Because the Products Have Been Stored Outside of Labeled Temperature Requirements
Summary Company Announcement Date: May 04, 2023 FDA Publish Date: May 04, 2023 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Product was stored outside of labeled temperature requirements. Company Name: Family Dollar Brand Name: Brand Name(s) Product Description: Product Description Over-The-Counter Drugs Company Announcement Family Dollar is initiating a voluntary retail…
Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication
Español Date Issued: July 20, 2022 UV wands may introduce health risks to the user or a person nearby. The U.S. Food and Drug Administration (FDA) is warning consumers about the potential risk of injury associated with the use of certain brands of ultraviolet (UV) wands. Do not use these UV wands for disinfection because…
Recall Notice – SD Biosensor, Inc. Requests Discontinuation of Use and Disposal of Specific Pilot™ COVID-19 At-Home Tests in the United States Due to Microbial Contamination in the Liquid Buffer Solution
Summary Company Announcement Date: May 04, 2023 FDA Publish Date: May 05, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to microbial contamination in the liquid buffer solution. Company Name: SD Biosensor, Inc. Brand Name: Brand Name(s) Product Description: Product Description COVID-19 At-Home Test Company Announcement SEOUL, South Korea, May 4,…