FDA Press Releases

• Published on June 10, 2021 - 04:00 GMT

  

  Stop Using Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication

  Date Issued: June 10, 2021 The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 8, 2021 - 18:23 GMT

  

  Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) - Lot Number: NMDS210011

  DATE NOTIFICATION INITIATED: June 2, 2021 PRODUCT / LOT NUMBER: FiberCel Fiber Viable Bone Matrix (“FiberCel”) Product Numbers: VBM9901, VBM9905, VBM9910 Lot Number: NMDS210011 MANUFACTURER: Aziyo Biologics, Inc. Richmond, CA REASON: Aziyo Biologics, Inc., …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 8, 2021 - 18:23 GMT

  

  2021 Biologics Recalls

  June 2, 2021 Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) - Lot Number: NMDS210011 Product Numbers- VBM9901, VBM9905, VBM9910 and Lot Number- NMDS210011 Aziyo Biologics, Inc., (“Aziyo”) is the manufacturer of record for …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 8, 2021 - 11:26 GMT

  

  Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Incorrect Transition to Safety Mode

  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: INGENIO Family of Pacemakers and CRT-Ps (includes models ADVANTIO DR EL, INGENIO DR …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 28, 2021 - 22:27 GMT

  

  Dash Xclusive Issues Voluntary Nationwide Recall of Imperia Elita Vitaccino Coffee Due to the Presence of Undeclared Sibutramine ...

  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 May 28, 2021 - 19:00 GMT

  

  Step-Har Medical Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts

  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 and/or installed by Step-Har Medical Models …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 28, 2021 - 16:20 GMT

  

  Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA Safety Communication

  Date Issued: May 28, 2021 The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold …

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• Published on May 28, 2021 - 16:19 GMT

  

  Lepu Medical Technology Recalls SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold ...

  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 Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid …

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• Published on May 27, 2021 - 18:39 GMT

  

  Update: FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators - Letter to Health Care ...

  May 27, 2021 The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH- …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 26, 2021 - 17:40 GMT

  

  Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication - Due to Risk of Serious Liver Injury, FDA ...

  [Posted 05/26/2021]  AUDIENCE: Patient, Health Professional, Pharmacy    ISSUE: The FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 25, 2021 - 19:51 GMT

  

  Medically Minded Hand Sanitizer– Nationwide Recall Expansion Due to The Presence of Undeclared Methanol

  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 May 24, 2021 - 18:43 GMT

  

  Medical Action Industries, Inc. 306 Recalls Medical Convenience Kits for Risk of Fungal (Aspergillus Penicillioides) 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 Medical Action Industries, Inc. 306 Medical Convenience Kits Kit Models and Lot Numbers: Please see …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 21, 2021 - 18:38 GMT

  

  Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration

  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 VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System Models and Serial Numbers: See …

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• Published on May 21, 2021 - 13:00 GMT

  

  Mammography Problems at Advanced Women Imaging in Guttenberg, NJ

  Date Issued: May 21, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Advanced Women Imaging, located in Guttenberg, NJ, on or after March 11, 2020, about possible problems with the quality of their mammograms. …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 20, 2021 - 17:40 GMT

  

  Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by HAIOU – Letter to Health Care Providers

  May 20, 2021 The U.S. Food and Drug Administration (FDA) is recommending health care facility risk managers, procurement staff, and health care providers stop using certain syringes and needles with needle safety devices manufactured by Guangdong Haiou …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 20, 2021 - 16:17 GMT

  

  Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety ...

  Date Issued: May 20, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Capitol Radiology, LLC, doing business as Laurel Radiology Services, located in Laurel, Maryland, on or after June 26, 2018, about possible …

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• Published on May 19, 2021 - 16:33 GMT

  

  Dibar Nutricional S. de R.L. De C.V. Issues Voluntary Nationwide Expanded Recall of Dibar Labs Hand Sanitizer Due to the Presence ...

  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 May 19, 2021 - 15:49 GMT

  

  Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication

  Date Issued: May 19, 2021 The U.S. Food and Drug Administration (FDA) is reminding the public and health care providers that results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 17, 2021 - 19:36 GMT

  

  Recall Expansion of Durisan Non-Alcohol Hand Sanitizer

  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 May 13, 2021 - 19:01 GMT

  

  Scentsational Soaps & Candles, Inc. Voluntarily Expands Nationwide Recall of Scented Hand Sanitizers Due to the Presence 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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry