FDA Press Releases

• Published on September 21, 2021 - 20:07 GMT

  

  IntegraDose Compounding Services, LLC Issues Voluntary Nationwide Recall of Cefazolin Injection Products Due to a Lack of ...

  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 September 20, 2021 - 16:01 GMT

  

  Medtronic Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, 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 Names: Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 17, 2021 - 15:37 GMT

  

  Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - ...

  September 17, 2021 The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of a potential for false positive results with the Alinity m SARS-CoV-2 AMP Kit, List Number 09N78-095, and Alinity m Resp-4-Plex …

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• Published on September 17, 2021 - 01:27 GMT

  

  Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline ...

  Summary Company Announcement Date: September 16, 2021 FDA Publish Date: September 16, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-nitroso-varenicline above acceptable daily intake level Company Name: Pfizer Brand Name: …

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• Published on September 15, 2021 - 16:01 GMT

  

  Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum ...

  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: NORMOFLO Irrigation Fluid Warmer and NORMOFLO Irrigation Warming Set Product Codes: …

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• Published on September 15, 2021 - 16:01 GMT

  

  Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices - Letter to Health Care Providers

  September 15, 2021 The U.S. Food and Drug Administration (FDA) is reminding health care providers about the use of certain fluid warmers and the potential for aluminum leaching and exposing the patient to high levels of aluminum. Based on information …

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• Published on September 15, 2021 - 14:12 GMT

  

  Urgent Voluntary Recall: Level 1 Fast Flow Fluid Warming System, NORMOFLO Fluid Warmer and Level 1 Normothermic I.V. Fluid ...

  DATE NOTIFICATION INITIATED: August 18, 2021 PRODUCT / LOT NUMBER: Level 1® Fluid Warmer Model Numbers: H-1000, H-500 Level 1® Fluid Warming System Model Numbers: H-1028, H-1200 NORMOFLO® Fluid Warmer Model Number: H-1025 Level 1® Normothermic I.V. Fluid …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 13, 2021 - 18:24 GMT

  

  Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Yeast, Mold,...

  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 September 11, 2021 - 14:46 GMT

  

  Aligned Medical Solutions Doing Business as Windstone Medical Packaging, Inc. Recalls Custom Convenience Kits Due to Cardinal ...

  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 (Include the following information) Product Names: Custom Convenience Kits containing the Cardinal …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 10, 2021 - 19:48 GMT

  

  All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination

  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: ultrasound gel products and lotions manufactured by Eco-Med are marketed by a number …

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• Published on August 30, 2021 - 17:02 GMT

  

  Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% (Lot # 14218, Exp. 09/2022) Due to Super ...

  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 August 26, 2021 - 14:44 GMT

  

  Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New York: FDA Safety Communication

  Date Issued: August 26, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Madison Avenue Radiology Center 190th Broadway, located in New York, New York, on or after February 26, 2019, about possible problems with …

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• Published on August 25, 2021 - 17:59 GMT

  

  Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng - Letter to Health Care Providers

  August 25, 2021  The U.S. Food and Drug Administration (FDA) is alerting health care facility risk managers, procurement staff, and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 24, 2021 - 16:32 GMT

  

  Bio-Medical Equipment Service Co. Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair ...

  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 Alaris Infusion Pump Module Model 8100 Bezel purchased or installed by Bio-Medical Equipment …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 24, 2021 - 15:54 GMT

  

  Baxter Issues Urgent Medical Device Correction for All Spectrum IQ Infusion Pumps to Reinforce Important Safety Information ...

  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 August 23, 2021 - 18:51 GMT

  

  Cardinal Health Recalls Monoject Saline Flush Prefilled Syringes for Risk of Air Re-entering Syringe Leading to Air Embolism

  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 Monoject Flush Prefilled Syringes (0.9% sodium chloride) Product Codes, All Lots: Product Code (SKU …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 20, 2021 - 15:57 GMT

  

  Cardinal Health Issues Nationwide Recall of Select Monoject™ Flush Prefilled Saline Syringes

  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 August 20, 2021 - 15:57 GMT

  

  UPDATE: Caution with Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication

  Date Issued: August 20, 2021 The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 20, 2021 - 12:54 GMT

  

  Cardinal Health Recalls Argyle UVC Insertion Tray Due to Missing Instructions for Use for the Safety Scalpel N11

  The FDA 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: Argyle UVC Insertion Tray containing Safety Scalpel N11 Product Codes:  Argyle UVC …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 18, 2021 - 14:20 GMT

  

  Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers

  August 18, 2021 The U.S. Food and Drug Administration (FDA) is informing health care providers, health care facility risk managers, and procurement staff to immediately stop using and discard all ultrasound gels and lotions manufactured by Eco-Med …

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