FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on July 31, 2024 - 18:14 GMT

Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes - Letter to Health Care Providers

July 31, 2024 The U.S. Food and Drug Administration (FDA), together with Health Canada, is raising awareness among health care providers and facilities about the safe use of Mega 2000 and Mega Soft Patient Return Electrodes by Megadyne Medical Products, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 24, 2024 - 14:39 GMT

Aurobindo Pharma USA, Inc. on Behalf of AuroHealth, Issues Voluntary Nationwide Recall of one (1) Lot of Healthy Living Over the ...

Summary Company Announcement Date: July 18, 2024 FDA Publish Date: July 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety - Mislabeling Company Name: Aurobindo Pharma USA, Inc. Brand Name: Brand Name(s …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 22, 2024 - 23:53 GMT

Main Products, Inc. Issues Voluntary Nationwide Recall of Umary Acido Hialuronico, Suplemento Alimenticio 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 July 22, 2024 - 21:59 GMT

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of One Lot of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) ...

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 July 17, 2024 - 14:15 GMT

Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number ...

Summary Company Announcement Date: July 16, 2024 FDA Publish Date: July 17, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeled with the incorrect strength on the carton Company Name: Endo USA, Inc Brand Name: Brand Name( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 17, 2024 - 00:04 GMT

GURU INC. Issues Voluntary Nationwide Recall of Infla-650 Herbal Dietary Supplement Capsules Due to Hidden Drug Ingredients

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 July 16, 2024 - 14:28 GMT

Baxter Issues Urgent Medical Device Recall for Volar System Single-Patient Use Circuit

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 July 15, 2024 - 22:48 GMT

SoloVital.com Issues Voluntary Nationwide Recall of Umary Acido Hialuronica, Suplemento Alimenticio 850 mg Capsules 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 July 15, 2024 - 19:50 GMT

Eye Injection Kit Recall: Bausch + Lomb/Synergetics Inc. Removes Certain I-Pack Injection Kits Due to Potential Non-Sterility

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product (Include the following …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 15, 2024 - 16:32 GMT

Ventilator Recall: Baxter Removes Life2000 Ventilator Due to Potential Failure of Battery Charging Dongle

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Name: Life2000 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 11, 2024 - 15:21 GMT

Ventilator Software Correction: Hamilton Medical Issues Correction for HAMILTON-C6 Medical Ventilators to Address Risk of Failed ...

This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 11, 2024 - 15:21 GMT

Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to ...

This recall involves updating instructions for using these devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 10, 2024 - 22:18 GMT

Baxter Issues Urgent Medical Device Recall for Life2000 Ventilator Due to Potential Battery Charger Dongle Damage

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 July 10, 2024 - 15:27 GMT

Philips Respironics Issues Additional Usage Instructions for Trilogy Evo Ventilators Related to Use of In-Line Nebulizers

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 July 10, 2024 - 15:05 GMT

Disruptions in Availability of BD BACTEC Blood Culture Media Bottles - Letter to Health Care Providers

July 10, 2024 The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of BD BACTEC blood culture media bottles because of recent supplier issues. The disruption in supply of this device is expected to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 10, 2024 - 10:09 GMT

Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May ...

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Name: Neo-Tee T- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 9, 2024 - 20:36 GMT

Do Not Use Medtronic NIM Standard and Contact EMG Endotracheal Tubes - Letter to Health Care Providers

July 9, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities to stop using NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes by Medtronic. These neural integrity …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2024 - 18:03 GMT

An Implantable Hypoglossal Nerve Stimulator Device Removal: Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse ...

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Inspire …

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Published on July 8, 2024 - 18:03 GMT

Radiofrequency (RF) Coils Correction: Philips North America LLC Updates Use Instructions For SENSE XL Torso (1.5T And 3.0T) Coils ...

This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 19:02 GMT

Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for OmniLab Advanced+ (OLA+) Ventilator due ...

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to …

Distribution channels: Healthcare & Pharmaceuticals Industry