FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on March 11, 2025 - 13:39 GMT

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 ...

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 March 11, 2025 - 12:24 GMT

Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals - Due to Increased Reports ...

AUDIENCE: Patient, Health Professional, Pharmacy, Immunology ISSUE: As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 11, 2025 - 11:59 GMT

Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

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 March 10, 2025 - 22:11 GMT

Smiths Medical Issues Urgent Medical Device Correction Informing Customers of a Potential Issue with Certain Sizes of Intubation ...

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 March 6, 2025 - 16:23 GMT

Infusion Pump Intermittent Connection Issue from Smiths Medical

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 March 6, 2025 - 16:23 GMT

False Alarm Issue with Infusion Pump from Smiths Medical

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 March 6, 2025 - 16:22 GMT

Infusion Pump Thermal Damage Issue from Smiths Medical

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 March 5, 2025 - 21:52 GMT

Update on Alert: Solution Set Issue from Baxter Healthcare Corporation

This communication was initially issued as part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health …

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Published on March 5, 2025 - 21:52 GMT

Update on Alert: Infusion Pump Software Issue from Fresenius Kabi USA

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 5, 2025 - 16:34 GMT

Early Alert: Infusion Pump Issue from Baxter Healthcare Corporation

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 3, 2025 - 19:27 GMT

Endovascular System Recall: Philips Removes and Discontinues Distribution of Tack Endovascular System Due to User Challenges That ...

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 Product Names: Tack Endovascular …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 3, 2025 - 19:27 GMT

Vaporizer Recall: Getinge Removes Vaporizer Sevoflurane Quick-Fil and Expands Recall of Vaporizer Sevoflurane Maquet Filling due ...

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. This is an expansion of the 2024 Class I …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 28, 2025 - 18:52 GMT

Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient ...

This recall involves updating the 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 February 28, 2025 - 17:11 GMT

Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from ...

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 February 28, 2025 - 16:46 GMT

Power Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ Power Assist ...

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: Speed …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 28, 2025 - 16:22 GMT

Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled Component, the Neo-Tee T-Piece Resuscitator ...

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: Regard …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 28, 2025 - 16:22 GMT

Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching ...

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: Single …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 27, 2025 - 02:00 GMT

Natural Dior LLC Issues Voluntary Nationwide Recall of Vitafer-L Gold Liquid Due to 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 February 26, 2025 - 00:26 GMT

Central Admixture Pharmacy Services (CAPS) Issues Nationwide Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in ...

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 25, 2025 - 19:35 GMT

Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System 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