FDA Press Releases - EIN Presswire - Press Release Distribution Service

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

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 …

Distribution channels:

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 …

Distribution channels:

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