FDA Press Releases

• Published on October 11, 2021 - 10:06 GMT

  

  Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results

  The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue FDA Safety Communication on October 5, 2021. The FDA has …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 30, 2021 - 23:13 GMT

  

  Coppertone® Issues Voluntary Nationwide Recall of Specific Lots of Pure & Simple SPF 50 Spray (2021 Launch), Sport Mineral SPF 50 ...

  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 29, 2021 - 18:27 GMT

  

  Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND: FDA Safety Communication

  Date Issued: September 29, 2021 The U.S. Food and Drug Administration (FDA) is warning consumers about the potential risk of injury associated with the use of the Safe-T-Lite UV WAND, manufactured by Max-Lux Corporation Limited. Use of Max-Lux Safe-T-Lite …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 27, 2021 - 16:09 GMT

  

  Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men – ...

  September 27, 2021 The U.S. Food and Drug Administration (FDA) is informing health care providers of recent information about the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion …

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• Published on September 27, 2021 - 01:23 GMT

  

  Eli Lilly and Company Issues Voluntary Nationwide Recall of One Lot of GLUCAGON® Emergency Kit Due to Loss of Potency

  Summary Company Announcement Date: September 25, 2021 FDA Publish Date: September 26, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Loss of potency Company Name: Eli Lilly and Company Brand Name: Product Description: Product …

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• Published on September 23, 2021 - 18:32 GMT

  

  Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia

  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  AMSORB PLUS PREFILLED G-CAN 1.0L  Product Codes and Lot Numbers: See Recall Database Entry  …

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• Published on September 22, 2021 - 21:41 GMT

  

  Cordis Recalls SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands Due to Potential for Marker Bands to Move 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  Cordis SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands Lot Numbers: See …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• 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