FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on May 13, 2021 - 00:11 GMT

Dibar Nutricional S. de R.L. De C.V. Issues Voluntary Nationwide Recall of DIBAR Labs Hand Sanitizer 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 …

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Published on May 12, 2021 - 12:24 GMT

Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying ...

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 HeartWare HVAD System Instructions for Use and Patient Manual that accompany components including …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 11, 2021 - 15:18 GMT

Yamtun7 Issues Voluntary Nationwide Recall of Poseidon Platinum 3500 Due to the Presence of Undeclared Tadalafil and Sildenafil

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, 2021 - 19:22 GMT

Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to ...

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 10, 2021 - 15:05 GMT

Medtronic Recalls Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks

October 5, 2021 Update: Medtronic has expanded this recall of remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks. Medtronic sent updated instructions to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 10, 2021 - 13:01 GMT

Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety ...

Date Issued: October 5, 2021 The U.S. Food and Drug Administration (FDA) is alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 8, 2021 - 13:21 GMT

Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum

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 Recirculator 8.0 Disposable Lavage Kit Product Code: 8100 Lot Numbers: 20021361, 20202106, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 30, 2021 - 22:22 GMT

Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub ...

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 30, 2021 - 16:54 GMT

Pacific Medical Group (DBA Avante Health Solutions) Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked 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. Recalled Product Alaris Infusion Pump Module Model 8100 Front Bezel, purchased and/or installed by Pacific Medical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 28, 2021 - 23:03 GMT

Scentsational Soaps & Candles, Inc. Issues Voluntary Nationwide Recall of Scented Hand Sanitizers Due to the Presence of 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 April 23, 2021 - 15:34 GMT

Cordis Recalls Precise PRO Rx US Carotid System Due to Risk of Separation in Device 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 Products Precise PRO Rx US Carotid System Product and Lot numbers: Full List of Affected Devices …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 20, 2021 - 23:57 GMT

BD Announces the Voluntary Recall of Specified Lots of ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator in the United States and U.S. ...

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 20, 2021 - 14:36 GMT

Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing ...

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 Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console (Bio-Console 560) Models: 560BC, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 20, 2021 - 02:19 GMT

Tenacore LLC Issues Nationwide Recall of Tenacore’s Replacement for the Front Bezel Assembly of the CareFusion Alaris 8100 ...

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, 2021 - 16:02 GMT

Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly Due to Possible Cracked 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. Recalled Product Alaris Infusion Pumps serviced by Tenacore Models: Model 8100 Serial Numbers: Please See Link Below …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 16, 2021 - 22:49 GMT

Durisan Announces a Voluntary Recall Expansion of its Antimicrobial 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 April 16, 2021 - 18:28 GMT

CareFusion 303, Inc. Recalls BD Alaris Pump Module Model 8100 Due to Risk of Stuck or Unresponsive Keys

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 BD Alaris Infusion Pump Module Affected Model Number: 8100 Affected Parts: 49000239; 49000346; …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 15, 2021 - 22:08 GMT

Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to ...

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 HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Product Numbers …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 12, 2021 - 17:28 GMT

Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum

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 ThermaCor 1200 Disposable Sets Disposable Set Models: PTC-1200, DNC-1200, PNC-1200 Distribution …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 12, 2021 - 17:28 GMT

Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac ...

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 Medtronic Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter …

Distribution channels: Healthcare & Pharmaceuticals Industry