FDA Press Releases

• Published on April 19, 2023 - 14:30 GMT

  

  Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment

  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: Ivenix Infusion System Model: LVP-0004 Devices Recalled in the U.S.: 1,546 Dates …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 13, 2023 - 19:46 GMT

  

  All Opioid Pain Medicines: Drug Safety Communication - FDA Updates Prescribing Information to Provide Additional Guidance for Safe ...

  [Posted 04/13/2023]  AUDIENCE: Patient, Health Professional, Pain Management, Pharmacy, Caregivers   ISSUE: The FDA is requiring several updates to the prescribing information for both immediate-release (IR) and extended release/long acting (ER/LA) opioid …

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• Published on April 12, 2023 - 17:20 GMT

  

  Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety ...

  Date Issued: April 12, 2023 The U.S. Food and Drug Administration (FDA) is recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 8, 2023 - 14:39 GMT

  

  Dräger Issues Worldwide Voluntary Recall Notification for Carina Sub-Acute Care Ventilators to Address Possible Contamination of ...

  Summary Company Announcement Date: August 01, 2023 FDA Publish Date: August 04, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product Safety/Potential Foreign Material Company Name: Drägerwerk AG & Co. KGaA Brand …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 7, 2023 - 14:29 GMT

  

  Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or ...

  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: Philips Respironics DreamStation1 (Uno Remediated Devices) Product Models: REP …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 6, 2023 - 20:09 GMT

  

  Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring ...

  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: FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 6, 2023 - 17:11 GMT

  

  Actualización sobre reportes de carcinoma de células escamosas en la cápsula alrededor de los implantes de seno: Comunicado de ...

  English Fecha de publicación: 8 de marzo de 2023 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está proporcionando una actualización sobre los reportes de carcinoma de células escamosas (SCC, por sus siglas en …

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• Published on April 5, 2023 - 17:59 GMT

  

  UPDATED: Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution ...

  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 April 5, 2023 - 16:18 GMT

  

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 5, 2023 - 13:26 GMT

  

  UPDATE - Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown

  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 April 5, 2023 - 11:00 GMT

  

  Family Dollar is Initiating a Voluntary Recall of Certain Over-the-Counter Drug Products Because the Products Have Been Stored ...

  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 March 31, 2023 - 20:02 GMT

  

  Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential ...

  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 March 31, 2023 - 17:23 GMT

  

  Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected ...

  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 March 30, 2023 - 15:29 GMT

  

  Evaluation of Safety Concerns with Certain Dental Devices Used on Adults – FDA Safety Communication

  Date Issued: March 30, 2023  The U.S. Food and Drug Administration (FDA) is evaluating safety concerns with the use of certain dental devices that are fixed (non-removable) palatal expanders used on adults to remodel the jaw or to treat conditions. The …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 28, 2023 - 04:00 GMT

  

  Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand ...

  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 March 23, 2023 - 17:22 GMT

  

  Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety Communication

  Date Issued: March 23, 2023 The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers about Exactech joint replacement devices manufactured by Exactech between 2004 and August 2021, and recalled in 2021 and 2022. Many …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 22, 2023 - 19:28 GMT

  

  Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the ...

  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 March 17, 2023 - 17:31 GMT

  

  Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown ...

  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 March 10, 2023 - 20:15 GMT

  

  Baxter Issues Urgent Medical Device Correction for LIFE2000 Ventilation System Due to Potential for Patient Desaturation When ...

  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 March 10, 2023 - 10:17 GMT

  

  KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a ...

  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