Summary Company Announcement Date: January 27, 2023 FDA Publish Date: January 30, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to presence of benzene Company Name: Edgewell Personal Care Brand Name: Brand Name(s) Banana Boat Product Description: Product Description Hair & Scalp Spray SPF 30 Company Announcement In the news release dated…
LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure
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: LifeSPARC System Product Model: LifeSPARC Controller, Model LS-1000 Distribution Dates: December 19, 2019 to November 17, 2022 Devices Recalled in the U.S.: 589 Date Initiated…
Emergent Recalls Certain RSDL (Reactive Skin Decontamination Lotion) Kits Due to Leak Potential
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: Emergent RSDL (Reactive Skin Decontamination Lotion) Kits Product Batch Number: 23005060 Distribution Dates: October 4, 2022 to October 14, 2022 Devices Recalled in the U.S.:…
Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump Through Damaged Balloon Catheter, Causing 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. Recalled Product Product Name: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Product Models: See Medical Device Recall Database entry Distribution Dates: March 6,…
Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product
Summary Company Announcement Date: January 09, 2023 FDA Publish Date: January 09, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Product discoloration Company Name: Spectrum Laboratory Products Inc. Brand Name: Brand Name(s) Product Description: Product Description Epinephrine bulk API Company Announcement Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline)…
Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of Potential Issues with CADD™ Infusion System Infusion Sets for Use with CADD Pumps
Summary Company Announcement Date: December 12, 2022 FDA Publish Date: January 05, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms. Company Name: Smith’s Medical Brand Name: Brand Name(s) Smith’s Medical Product Description: Product Description CADD Infusion System Infusion Sets…
ACTUALIZACIÓN: Se retiran del mercado ciertos ventiladores, máquinas BiPAP y máquinas CPAP de Philips Respironics debido a posibles riesgos para la salud: Comunicado de seguridad de la FDA
English ACTUALIZACIÓN – 22 de diciembre de 2022: La FDA emitió un comunicado de seguridad para proporcionar información adicional a pacientes, cuidadores y proveedores de atención médica sobre dos problemas recientes en ciertos ventiladores Trilogy 100 y Trilogy 200 de Philips Respironics (Philips) reacondicionados. Estos ventiladores Philips Trilogy 100 y Trilogy 2000 fueron retirados del…
Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The Presence of Visible Glass Particulates
Summary Company Announcement Date: December 22, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Visible Glass Particulates Company Name: Hospira, Inc. Brand Name: Brand Name(s) Hospira, Inc. Product Description: Product Description Vancomycin Injection Company Announcement December 22, 2022 – NEW YORK, NY., Hospira, Inc., a…
Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 Due to Product Mix-Up
Summary Company Announcement Date: December 23, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling Company Name: Accord Healthcare, Inc Brand Name: Brand Name(s) Product Description: Product Description Daptomycin for Injection Company Announcement – December 22, 2022 – Durham, North Carolina, Accord Healthcare, Inc. is voluntarily recalling…
GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to Microbial Contamination
Summary Company Announcement Date: December 23, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is contaminated with Bacillus licheniformis and Bacillus sonorensis. Company Name: GFA Production Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description After Burn® Cream and First Aid Kits containing After…