FDA Press Releases

• Published on January 26, 2023 - 14:27 GMT

  

  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: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 25, 2023 - 17:41 GMT

  

  Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump ...

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 25, 2023 - 17:41 GMT

  

  2023 Medical Device Recalls

  The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 10, 2023 - 03:53 GMT

  

  Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

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• Published on January 5, 2023 - 16:19 GMT

  

  Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of Potential Issues with CADD™ Infusion System ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

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• Published on December 27, 2022 - 05:00 GMT

  

  Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

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• Published on December 27, 2022 - 05:00 GMT

  

  Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The ...

  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) …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on December 27, 2022 - 05:00 GMT

  

  GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on December 22, 2022 - 20:15 GMT

  

  Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and ...

  Date Issued: December 22, 2022 The U.S. Food and Drug Administration (FDA) is providing additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on December 21, 2022 - 20:56 GMT

  

  Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril Tablets Due to Potential Presence of N-...

  Summary Company Announcement Date: December 21, 2022 FDA Publish Date: December 21, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of nitrosamine impurity, N-Nitroso-Quinapril Company Name: Lupin Pharmaceuticals Inc. …

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• Published on December 20, 2022 - 21:01 GMT

  

  Whele LLC Recalls Mighty Bliss Electric Heating Pads Due to Injury Risks Including Electric Shocks, Skin Burns, and Rashes

  The recall described in this notice is for the same issue that was announced in Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication | FDA on October 25, 2022. The FDA has identified this as a Class I recall …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on December 20, 2022 - 16:32 GMT

  

  Arrow International, LLC, subsidiary of Teleflex, Inc Recalls Arrow AutoCAT 2, AC3 Intra-Aortic Balloon Pumps for Unexpectedly ...

  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: Arrow AutoCAT 2, AutoCAT 2 Refurbished, AeroautoCAT 2, AutoCAT 2 Wave, AutoCAT 2 …

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• Published on December 16, 2022 - 20:15 GMT

  

  Teleflex and Arrow International, LLC Recall Arrow MAC Two-Lumen Central Venous Access and Pressure Injectable Arrowg+ard Blue ...

  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: Arrow MAC Two-Lumen Central Venous Access Kits; Arrow Pressure Injectable Arrowg+ard …

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• Published on December 12, 2022 - 20:20 GMT

  

  Voluntary Recall of Three Detect Covid-19 Test Lots

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on December 12, 2022 - 17:36 GMT

  

  2020 Letters to Health Care Providers

  The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on December 6, 2022 - 05:00 GMT

  

  Actualización de los sistemas endovasculares de injerto de AAA Endologix AFX y el riesgo de endofuga de tipo III: Comunicado de ...

  English Fecha de emisión: 6 de diciembre de 2022 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está actualizando nuestro comunicado de seguridad de enero de 2022 (en inglés) sobre el uso de los injertos …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on November 29, 2022 - 20:48 GMT

  

  Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-...

  Summary Company Announcement Date: November 28, 2022 FDA Publish Date: November 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: Exela Pharma Sciences, LLC Brand Name: Product Description: Product …

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• Published on November 23, 2022 - 17:42 GMT

  

  Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment

  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: WatchCare Incontinence Management System (IMS)  Product Models:  P7900B Centrella …

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• Published on November 23, 2022 - 00:00 GMT

  

  Prolia (denosumab) by Amgen: Drug Safety Communication - FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis

  [Posted 11/22/2022]  AUDIENCE: Patient, Health Professional, Pharmacy    ISSUE: The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on November 22, 2022 - 05:00 GMT

  

  ACTUALIZACIÓN: Se retiran del mercado ciertos ventiladores, máquinas BiPAP y máquinas CPAP de Philips Respironics debido a ...

  ACTUALIZACIÓN - 22 de noviembre de 2022: La FDA actualizó este comunicado de seguridad para proporcionar información actualizada sobre los informes de dispositivos médicos (en inglés) (MDR, por sus siglas en inglés) recibidos del 1 de agosto de 2022 al 31 …

  Distribution channels: Healthcare & Pharmaceuticals Industry