FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on October 1, 2022 - 00:59 GMT

LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure

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: LifeSPARC System Product Model: LifeSPARC Controller, Model LS-1000 Distribution …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 28, 2022 - 23:32 GMT

Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared ...

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 September 27, 2022 - 16:47 GMT

Eugia US LLC Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 23, 2022 - 15:55 GMT

Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern

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: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+ Product Models: A- …

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Published on September 20, 2022 - 12:34 GMT

Salon Technologies, Inc. Issues Voluntary Nationwide Recall of Antica Ocean Citron Hand Sanitizer ( Alcohol ) Gel 65% 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 September 16, 2022 - 19:02 GMT

Voluntary Recall of Certain Colgate Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature ...

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 September 16, 2022 - 18:26 GMT

Voluntary Recall of Certain Over-the-Counter Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature ...

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 September 16, 2022 - 17:15 GMT

Update: Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health ...

September 16, 2022 The U.S. Food and Drug Administration (FDA) is updating the Letter to Health Care Providers issued on April 27, 2022, to ensure health care providers in the operating room setting are aware of the voluntary recall initiated by Medtronic …

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Published on September 15, 2022 - 13:34 GMT

Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and ...

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: Clearlink Basic Solution Set with Duovent Product Code: 2R8403 (all lots within …

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Published on September 12, 2022 - 11:04 GMT

Remel, Inc Recalls Thermo Scientific Gram Negative IVD AST Sensititre Plate for risk of potential false susceptible 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 Product Name: Thermo Scientific Gram Negative IVD AST Sensititre Plate Catalog Number: GN2F, GN3F …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 12, 2022 - 04:00 GMT

Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube for 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 Name: NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 29, 2022 - 17:32 GMT

Hamilton Medical AG Recalls Hamilton-C6 Intensive Care Ventilator Due to Potential Water Ingress that May Cause Breathing Support ...

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: HAMILTON-C6 Intensive Care Ventilator Product Model Numbers: See Recall Database …

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Published on August 29, 2022 - 15:17 GMT

Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication

Date Issued: August 29, 2022 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or …

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Published on August 29, 2022 - 14:53 GMT

Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Due to Faster Than Expected Flow Rates That May Impact Infusion ...

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: Intera 3000 Hepatic Artery Infusion Pump Models: See Recall Database entry Devices …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 25, 2022 - 14:00 GMT

Medtronic Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery Failure

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: Medtronic HVAD Batteries Model Numbers: 1650DE Devices Being Recalled: 23,372 Dates …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 22, 2022 - 23:32 GMT

Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), 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 August 19, 2022 - 04:00 GMT

Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver ...

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 Device Use Medtronic Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 18, 2022 - 17:35 GMT

2022 Letters to Health Care Providers

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2022 - 10:12 GMT

Dewei Medical Equipment Co. Recalls DNA/RNA Preservation Kits That Are Not Authorized, Cleared, or Approved by the FDA

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: Dewei Medical Equipment Co. DNA/RNA Preservation Kits Product Catalog Number: DW- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 11, 2022 - 17:10 GMT

At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication

Date Issued: August 11, 2022 Perform repeat, or serial testing following a negative result on any at-home COVID-19 test, whether or not you have symptoms. The U.S. Food and Drug Administration (FDA) is advising people to perform repeat, or serial, testing …

Distribution channels: Healthcare & Pharmaceuticals Industry