FDA Press Releases

• Published on May 19, 2022 - 20:19 GMT

  

  Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA ...

  UPDATE: On May 19, 2022, the FDA updated this safety communication to provide the latest information about medical device reports (MDRs) associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics …

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• Published on May 19, 2022 - 19:59 GMT

  

  FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

  UPDATE: On May 19, 2022, the FDA updated this web page to help ensure patients and providers have important information about the recall of these critical devices. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 16, 2022 - 17:48 GMT

  

  Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (...

  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: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and Joysbio SARS-CoV-2 Antigen Rapid …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 13, 2022 - 20:42 GMT

  

  Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm

  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: Avanos Medical Cortrak*2 Enteral Access System Product Codes and Serial Numbers: See …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 12, 2022 - 09:28 GMT

  

  UPDATE: Impella RP System Post-Approval Study Results and Updated Labeling - Letter to Health Care Providers

  December 5, 2022 The U.S. Food and Drug Administration (FDA) is issuing this update to our previous letter to health care providers to inform the health care community of the final post-approval study (PAS) results and updated labeling for the Impella RP …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 11, 2022 - 20:27 GMT

  

  Insulet Issued Voluntary Medical Device Correction for Omnipod DASH® Personal Diabetes Manager on October 17, 2022

  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 10, 2022 - 16:28 GMT

  

  SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, 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. The devices described in this recall notice are the same devices announced in the FDA safety communication, Do Not …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 10, 2022 - 15:41 GMT

  

  Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication

  Date Issued: May 10, 2022 The U.S. Food and Drug Administration (FDA) is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). This test is not authorized, cleared, or approved by the FDA for distribution or use …

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• Published on May 9, 2022 - 14:55 GMT

  

  Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by 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 Name: Accula SARS-CoV-2 Test Product Codes: QJR Lot Numbers: See recall database entry …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 6, 2022 - 17:41 GMT

  

  Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – ...

  May 6, 2022 The U.S. Food and Drug Administration (FDA) is evaluating the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following hemodialysis machines …

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• Published on April 28, 2022 - 21:03 GMT

  

  Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, ...

  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: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Codes: 83QKP Lot Numbers: See …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 28, 2022 - 20:21 GMT

  

  Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers

  The U.S. Food and Drug Administration (FDA) is alerting health care providers to the possibility that patients who have the Medtronic Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may have a welding defect in …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 27, 2022 - 15:06 GMT

  

  Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes – Letter to Health Care Providers

  April 27, 2022 The U.S. Food and Drug Administration (FDA) is evaluating the potential risk of airway obstruction when using silicone-based electromyogram (EMG) endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 26, 2022 - 15:18 GMT

  

  Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During ...

  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: Harmony Delivery Catheter System Product Codes and Batch Numbers: See database entry. …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 23, 2022 - 03:21 GMT

  

  Pfizer Voluntary Nationwide Recall of Lots of ACCUPRIL® (Quinapril HCl) Due to N-Nitroso-Quinapril Content

  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 April 19, 2022 - 18:12 GMT

  

  Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication

  Discuss the results of genetic prenatal screening tests with a genetic counselor or other health care provider.Date Issued: April 19, 2022 The U.S. Food and Drug Administration (FDA) is warning patients and health care providers about the risks of false …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 12, 2022 - 22:56 GMT

  

  Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin ...

  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 11, 2022 - 17:32 GMT

  

  Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers

  April 11, 2022 The U.S. Food and Drug Administration (FDA) is reminding health care providers about the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO). LVO is an obstruction …

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• Published on April 11, 2022 - 12:25 GMT

  

  Teleflex Announces Worldwide Recall of Gibeck® Iso-Gard® Filter

  Summary Company Announcement Date: November 03, 2022 FDA Publish Date: November 04, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Bacterial and viral filters Company Name: Teleflex Incorporated Brand Name: Brand Name …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 8, 2022 - 20:25 GMT

  

  VI-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral ...

  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