FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on July 8, 2021 - 17:29 GMT

Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers

July 8, 2021 The U.S. Food and Drug Administration (FDA) is informing health care providers about potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. The FDA is also …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 7, 2021 - 19:40 GMT

Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results

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 Lyra SARS-CoV-2 Assay (M120) Lot codes: 031620A, 031620B, 031620C, 032320, 032420, 032720, 032820A, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 30, 2021 - 19:25 GMT

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

Date Issued: June 30, 2021 The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 30, 2021 - 19:25 GMT

Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care ...

June 30, 2021 The U.S. Food and Drug Administration (FDA) is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 25, 2021 - 20:39 GMT

Smiths Medical Recalls Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes for Skewed Graduated Marks on Syringe Barrel That ...

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 Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes Models and Lot Model Number Name Lot …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 25, 2021 - 16:51 GMT

Avid Medical Recalls Medical Convenience Kits for Risk of Fungal 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 Adult Chest Tube Tray Fistula On-Off Kit Fistula (On/Off All in One bag) Dialysis Access Part and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 25, 2021 - 16:51 GMT

DeRoyal Industries Recalls Surgical Procedure Packs for Mislabeled Lidocaine

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 DeRoyal Pacemaker Tray Pgybk Lot Number 54239375, exp. 02/01/2022 DeRoyal Heart Cath Procedure …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 25, 2021 - 14:13 GMT

Flexible Bronchoscopes and Updated Recommendations for Reprocessing: FDA Safety Communication

Date Issued: June 25, 2021 The U.S. Food and Drug Administration (FDA) is providing updated information about medical device adverse event reports and recommendations for health care providers on bronchoscopes. This is a supplement to the 2015 safety …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 22, 2021 - 19:34 GMT

Sanit Technologies Adds Label Clarification to Existing Voluntary Hand Sanitizer Recall

COMPANY ANNOUNCEMENT Some product packaging form labels are being added to ensure last stage of recall is complete When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 22, 2021 - 17:15 GMT

Prairie Wolf Spirits, Inc. Issues Voluntary Nationwide Recall of Prairie Wolf Distillery Hand Sanitizer Packed in 16.9 Oz. and 20 ...

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 June 18, 2021 - 02:29 GMT

Smiths Medical Issues Worldwide Notification Regarding the Recall of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe ...

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 June 16, 2021 - 12:37 GMT

Infusion Pump Repair 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 Infusion Pump Repair …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 15, 2021 - 23:43 GMT

Philips Issues a Recall Notification* to Mitigate Potential Health Risks Related to the Sound Abatement Foam Component in Certain ...

Summary Company Announcement Date: June 14, 2021 FDA Publish Date: June 15, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 12, 2021 - 23:52 GMT

Gilead Issues A Voluntary Nationwide Recall of Two Lots of Veklury® (Remdesivir) Due to Presence of Glass ...

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 June 12, 2021 - 00:50 GMT

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the ...

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 June 10, 2021 - 18:55 GMT

Sodium Citrate Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel

June 10, 2021 The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing significant interruptions in the supply of sodium citrate blood specimen collection (light blue top) tubes because of an increase in demand and recent vendor …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 10, 2021 - 17:21 GMT

Stop Using Innova 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 SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the test has not …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 10, 2021 - 17:21 GMT

Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results

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 Innova SARS-CoV-2 Antigen Rapid Qualitative Test (also distributed under the names Innova COVID-19 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 10, 2021 - 13:23 GMT

Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter Due to Risk of Breaks During Use

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 ZOOM 71 Reperfusion Catheter Product Codes and Lot Numbers: See Recall Database Entry Devices …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 10, 2021 - 10:25 GMT

DeRoyal Industries, Inc. Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set Due to the Possibility ...

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: DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set …

Distribution channels: Healthcare & Pharmaceuticals Industry