FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on February 8, 2023 - 18:41 GMT

Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or ...

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. The devices described in this recall notice are the same devices announced in the FDA safety communication Do Not …

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Published on February 7, 2023 - 21:45 GMT

2023 Safety Communications

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 7, 2023 - 21:45 GMT

Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ

Update - February 7, 2023: The Mammography Quality Standards Act (MQSA) certificate for Advanced Women Imaging, located at 6414 Bergenline Avenue, West New York, NJ (Bergenline) was revoked until January 4, 2025. The facility is currently unaccredited, …

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Published on February 7, 2023 - 05:00 GMT

Actualizado: Problemas de mamografía en Advanced Women Imaging en Guttenberg, NJ

English Actualización - 7 de febrero de 2023: El certificado de la Ley de estándares de calidad de mamografía (MQSA, por sus siglas en inglés) para Advanced Women Imaging (en inglés), en 6414 Bergenline Avenue, West New York, NJ (Bergenline) fue revocado …

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Published on February 3, 2023 - 10:25 GMT

Apotex Corp. Issues Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% Due to Cracks that Have ...

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 2, 2023 - 23:29 GMT

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible 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 View Product Photos …

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Published on February 2, 2023 - 19:49 GMT

Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or ...

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: CADD infusion system Administration Sets and Cassette Reservoirs Product Models: …

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Published on January 30, 2023 - 19:55 GMT

Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene – ...

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 January 30, 2023 - 17:11 GMT

Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect

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: Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters (Mahurkar …

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Published on January 27, 2023 - 16:07 GMT

LivaNova (TandemLife) Adds Software Update to Recall for LifeSPARC System for Risk of Unintentional Extended Pump Stop During ...

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 …

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Published on January 26, 2023 - 14:27 GMT

Emergent Recalls Certain RSDL (Reactive Skin Decontamination Lotion) Kits Due to Leak Potential

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: Emergent RSDL (Reactive Skin Decontamination Lotion) Kits Product Batch Number: …

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Published on January 25, 2023 - 17:41 GMT

Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump ...

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: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic …

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Published on January 25, 2023 - 17:41 GMT

2023 Medical Device Recalls

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.

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Published on January 12, 2023 - 14:45 GMT

Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject ...

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 Names: BD Alaris Syringe Module, BD Alaris PCU, and Alaris PCA Module Model Numbers: 8110, …

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Published on January 12, 2023 - 10:27 GMT

Eitan Medical Ltd Recalls Sapphire Infusion Pumps for Failure to Detect Air in the Line

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 voluntary correction, not a product removal.  Eitan Medical Ltd will be updating …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2023 - 15:57 GMT

The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity ...

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 January 11, 2023 - 10:49 GMT

Cardinal Health, Inc. Issues Voluntary Nationwide Recall of Certain LEADER™ Brand Eye Drops Supplied by Velocity Pharma, LLC Due ...

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 January 10, 2023 - 03:53 GMT

Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical ...

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 January 5, 2023 - 16:19 GMT

Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of Potential Issues with CADD™ Infusion System ...

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 January 3, 2023 - 15:01 GMT

Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced - Letter to Health Care ...

March 1, 2023 The U.S. Food and Drug Administration (FDA) is alerting health care facilities and providers about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The disposable part is the HLS Set …

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