FDA Press Releases - EIN Presswire - Press Release Distribution Service

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 …

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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 …

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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 …

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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 …

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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. …

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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 …

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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 …

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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 …

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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 …

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Published on April 8, 2022 - 12:31 GMT

Plastikon Healthcare Expands Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum ...

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 April 5, 2022 - 14:11 GMT

Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Date Issued: April 5, 2022 The U.S. Food and Drug Administration (FDA) is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components as well as …

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Published on April 4, 2022 - 17:22 GMT

UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers

April 4, 2022 As the U.S. Food and Drug Administration (FDA) continues to evaluate the risk of patient infections and contamination issues associated with reprocessed urological endoscopes, the FDA is aware that the current reprocessing instructions for …

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Published on March 30, 2022 - 21:59 GMT

Iodine-Containing Contrast Media: Drug Safety Communication - FDA Recommends Thyroid Monitoring in Babies and Young Children Who ...

[Posted 03/30/2022] AUDIENCE: Pediatrics, Radiology, Health Professional, Patient, Caregiver, Pharmacy ISSUE: The FDA approved a new warning to the prescribing information for the entire class of iodinated contrast media (ICM) injections and monitoring …

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Published on March 30, 2022 - 21:23 GMT

Unilever Issues Voluntary Nationwide Recall of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Suave 24-Hour Protection ...

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