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There were 164 press releases posted in the last 24 hours and 441,617 in the last 365 days.

FDA Press Releases

2,267 Press Releases

Published on June 11, 2023 - 15:38 GMT

Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling

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: Pressure Injectable Central Venous Catheters Product Codes: See table below …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 10, 2023 - 11:59 GMT

Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Sinus, and Restore Sinus Spray Products 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 June 9, 2023 - 13:13 GMT

Oxygenator Devices Used for Extracorporeal Circulation - Letter to Health Care Providers

June 9, 2023 The U.S. Food and Drug Administration (FDA) is providing information to health care providers and facilities on the use of oxygenators in extracorporeal circulation. On May 18, 2023, Getinge/Maquet issued an Urgent Medical Device Removal …

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Published on May 26, 2023 - 16:47 GMT

FDA Updating Warnings to Improve Safe Use of Prescription Stimulants Used to Treat ADHD and Other Conditions.

[Posted 05/26/2023] AUDIENCE: Patient, Health Professional, Pharmacy, Psychiatry, Pediatrics ISSUE: The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 25, 2023 - 15:55 GMT

SD BioSensor, Inc. Recalls Certain Pilot COVID-19 At-Home Tests for Potential Bacteria Contamination

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: Pilot COVID-19 At-Home Tests Product Codes: See Safety Communication Distribution …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 24, 2023 - 19:34 GMT

Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can ...

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: Seattle PAP Plus, VentStar Basic (P)180, VentStar Basic(P)250, VentStar Watertrap ( …

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Published on May 22, 2023 - 19:44 GMT

ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that ...

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: Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Battery …

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Published on May 19, 2023 - 23:24 GMT

Novis PR LLC Issues Voluntary Recall of G-Supress DX Pediatric Drops Due to Incorrect Packaging

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 May 19, 2023 - 21:05 GMT

Novis PR LLC Emite Retiro Voluntario de Gotas Pediátricas G-Supress DX Debido a Empaque Incorrecto

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 May 12, 2023 - 21:09 GMT

BearCare Voluntarily Recalls Rechargeable Walnut Thermometer Due to the Potential for Skin Burns

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 May 12, 2023 - 12:37 GMT

Cordis US Corp Recalls INFINITI Angiographic Catheter due to Products Being Shipped Without Undergoing Sterilization Procedures

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: Cordis INFINITI Angiographic Catheter Product Codes: DQO Lot Number: 18223410 …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 10, 2023 - 17:00 GMT

Risk of Invasive Disease in Preterm Infants Given Probiotics Formulated to Contain Live Bacteria or Yeast

AUDIENCE: Consumers, Patients, Health Professionals ISSUE: The U.S. Food and Drug Administration (FDA) is providing important safety information to healthcare providers on the use of products containing live bacteria or yeast (commonly called probiotics) …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 10, 2023 - 04:00 GMT

ACTUALIZACIÓN: Uso del dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicación de seguridad de la ...

English Fecha de publicación: 10 de mayo de 2023 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está proporcionando otra actualización sobre el sistema de dispositivos Renuvion/J-Plasma de Apyx Medical con …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 9, 2023 - 10:09 GMT

WEFUN Inc Issues Voluntary Nationwide Recall of WEFUN Capsules Due to Presence of Undeclared Sildenafil

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 May 6, 2023 - 11:03 GMT

Non-sterile, Single-use Pneumatic Tourniquet Cuffs Conservation Strategies - Letter to Health Care Providers

June 5, 2023 The U.S. Food and Drug Administration (FDA) is aware of health care facilities and providers experiencing localized supply constraints of non-sterile, single-use pneumatic tourniquet cuffs in the United States. These devices are mainly used in …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 6, 2023 - 07:51 GMT

Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support

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: Impella 5.5 with SmartAssist Product Code: 0550-0008 Product Serial Numbers: See …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 5, 2023 - 18:29 GMT

Recall Notice - SD Biosensor, Inc. Requests Discontinuation of Use and Disposal of Specific Pilot™ COVID-19 At-Home Tests in 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 …

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Published on April 28, 2023 - 19:36 GMT

Teva Initiates Voluntary Nationwide Recall of Specific Lots of FENTANYL Buccal Tablets CII Due to a Labeling Error

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 April 27, 2023 - 19:57 GMT

Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and ...

April 27, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers and laboratory personnel about a cybersecurity vulnerability affecting the Universal Copy Service (UCS) software in the Illumina MiSeqDx, NextSeq 550Dx, iScan, …

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Published on April 26, 2023 - 21:25 GMT

Gear Isle Issues Voluntary Nationwide Recall of Pro Power Knight Plus, NUX Male Enhancement and DYNAMITE SUPER 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

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