FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on February 5, 2022 - 17:57 GMT

Philips Respironics Issues Voluntary Recall Notification/Field Safety Notice* for the V60 Ventilator Product Family

Summary Company Announcement Date: April 22, 2022 FDA Publish Date: May 02, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description A potential issue with the electrical circuit in these ventilators that controls the 35V power …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 5, 2022 - 12:42 GMT

Fagron Inc. Issues Voluntary Nationwide Recall of SyrSpend SF Cherry Due to Microbial Contamination

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 February 4, 2022 - 21:06 GMT

SD BIOSENSOR, Issues Notification of Voluntary Recall of ‘STANDARD Q COVID-19 Ag Home Test’

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 February 4, 2022 - 20:16 GMT

Vyaire Medical Issues Voluntary Correction for Certain bellavista™ Ventilators in Specific Software Configurations

Summary Company Announcement Date: February 04, 2022 FDA Publish Date: February 04, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Ventilators can cease ventilation and generate a technical failure alarm 305 Company …

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Published on February 4, 2022 - 19:26 GMT

Junp LLC Issues Voluntary Nationwide Recall of MegMan Performance Booster Capsules Due to the Presence of Tadalafil

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 February 4, 2022 - 17:49 GMT

Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication

Date Issued: February 4, 2022 The U.S. Food and Drug Administration (FDA) is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 3, 2022 - 16:00 GMT

Ukoniq (umbralisib): Drug Safety Communication - FDA Investigating Possible Increased Risk of Death with Lymphoma

[Posted 02/03/2022] AUDIENCE: Oncology, Patient, Health Professional, Pharmacy   ISSUE: The FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) approved to treat two specific types of lymphomas, which are …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 31, 2022 - 17:43 GMT

Esupplementsales, LLC Issues a Nationwide Recall All Lots of Hard Dawn Due to the Presence of Undeclared Tadalafil

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 January 28, 2022 - 20:50 GMT

Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication

Date Issued: January 28, 2022 The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 28, 2022 - 20:50 GMT

Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious adverse health consequences or death. Recalled Product Empowered Diagnostics, LLC CovClear COVID-19 Rapid Antigen Test and ImmunoPass …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 28, 2022 - 17:02 GMT

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, 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 …

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Published on January 27, 2022 - 22:01 GMT

Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination

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 January 26, 2022 - 19:51 GMT

Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions

In June 2021, Philips Respironics voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (CPAP) machines due to potential health risks. The polyester- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 26, 2022 - 19:51 GMT

Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam

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 * Note: Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam …

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Published on January 21, 2022 - 14:52 GMT

Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage 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 HawkOne Directional Atherectomy System Product Codes and Lot Numbers: See Recall Database Entry …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 19, 2022 - 21:53 GMT

UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel

January 19, 2022 The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing significant interruptions in the supply of several blood specimen collection (blood draw) tubes because of an increase in demand during the COVID-19 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 19, 2022 - 19:43 GMT

Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of ...

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: Vaporizer Sevoflurane, Maquet Filling for Flow Family Anesthesia Systems Model …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 19, 2022 - 16:26 GMT

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), ...

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 January 13, 2022 - 16:12 GMT

Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems – FDA Safety Communication

Date Issued: January 13, 2022 The U.S. Food and Drug Administration (FDA) is updating the December 2020 safety communication on the use of Endologix AFX endovascular grafts. This update includes a summary of information from our November 2021 advisory …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 12, 2022 - 18:42 GMT

Buprenorphine: Drug Safety Communication - FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to ...

[Posted 01/12/2022] AUDIENCE: Dentistry, Anesthesiology, Patient, Health Professional, Pharmacy ISSUE: The FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems …

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