FDA Press Releases - EIN Presswire - Press Release Distribution Service

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 …

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Published on February 21, 2025 - 18:47 GMT

Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to ...

This recall involves the potential need for device explant. 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 following the What to Do section below. Affected …

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Published on February 21, 2025 - 02:32 GMT

One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and ...

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 18, 2025 - 20:12 GMT

BD Announces Voluntary Worldwide Recall for One Lot of ChloraPrep™ Clear 1 mL Applicators Due to Fungal 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 Summary Company …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 14, 2025 - 17:38 GMT

ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq 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

Published on February 14, 2025 - 16:55 GMT

Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due ...

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 February 10, 2025 - 16:37 GMT

Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing Circuits due to Venturi Component ...

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/Models …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 7, 2025 - 14:44 GMT

Extended-Release Stimulants for ADHD: FDA Drug Safety Communication - FDA Requires Expanded Labeling about Weight Loss Risk in ...

Action Will Harmonize Labeling Across Extended-Release Stimulant Drug Class AUDIENCE: Patient, Health Care Professional, Pharmacy, Pediatrics ISSUE: The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 6, 2025 - 16:30 GMT

Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular

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 February 6, 2025 - 16:30 GMT

Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub ...

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

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 5, 2025 - 18:24 GMT

Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due 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 Product Names: TRUAIRE-5 02 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 5, 2025 - 17:03 GMT

Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming ...

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 …

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Published on February 5, 2025 - 16:09 GMT

FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or ...

Date Issued: February 5, 2025 The U.S. Food and Drug Administration (FDA) is alerting patients who use diabetes devices and their caregivers of reports where users of continuous glucose monitors (CGMs), insulin pumps, automated insulin dosing systems, and …

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