FDA Press Releases - EIN Presswire - Press Release Distribution Service

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

Published on June 28, 2024 - 19:02 GMT

Left Ventricular Assist System (LVAS) Monitor Correction: Abbott Medical Issues Correction for HeartMate LVAS System Monitor due ...

This recall involves correcting 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 without …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 27, 2024 - 17:18 GMT

Ventilator Correction: ZOLL Medical Corporation Updates Use Instructions For 731 Ventilators Due to Missing MRI Safety Information ...

This recall involves updating instructions for using 731 Ventilator 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 27, 2024 - 16:09 GMT

Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to ...

This recall involves updating instructions for using BiPAP V30, BiPAP A30, BiPAP A40 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 26, 2024 - 18:56 GMT

American Health Packaging on Behalf of BluePoint Laboratories Issues Voluntary Nationwide Recall for Potassium Chloride Extended-...

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 25, 2024 - 15:06 GMT

Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 ...

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 13, 2024 - 20:58 GMT

Electrode Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for Risk of Serious Burn Injuries to ...

This recall involves removing 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 Figure 1: MEGADYNE MEGA SOFT …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 13, 2024 - 20:08 GMT

Getinge Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient and Health Care Professional Exposure to Toxic Chemical ...

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: Vaporizer Sevoflurane Maquet Filling Product Code: 6682282 Distributed Serial Numbers …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 13, 2024 - 19:30 GMT

Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits for Manufacturing ...

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. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Name: Arrow FiberOptix …

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