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Published on March 17, 2023 - 17:31 GMT

Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown ...

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 March 10, 2023 - 20:15 GMT

Baxter Issues Urgent Medical Device Correction for LIFE2000 Ventilation System Due to Potential for Patient Desaturation When ...

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 March 10, 2023 - 10:17 GMT

KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a ...

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 March 8, 2023 - 14:36 GMT

UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication

Date Issued: March 8, 2023 The U.S. Food and Drug Administration (FDA) is providing an update on reports of squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. Previously, on September 8, 2022, the FDA released a …

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Published on March 7, 2023 - 18:19 GMT

Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health ...

March 7, 2023 The U.S. Food and Drug Administration (FDA) is continuing to evaluate the potential risk of exposure to toxic compounds when using dialysis systems. On May 6, 2022, the FDA issued a Letter to Health Care Providers about the evaluation of the …

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Published on March 4, 2023 - 21:58 GMT

Abbott Issues Safety Notification for FreeStyle Libre® Family of Readers in the U.S.

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 3, 2023 - 23:59 GMT

Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility

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 3, 2023 - 23:11 GMT

All Allergenic Extracts for Diagnosis of Food Allergy: FDA Safety Communication - FDA Requires Warning about Anaphylaxis Following ...

[Posted 03/03/2023] AUDIENCE: Allergy and Immunology, Pediatrics, Health Professional, Patient ISSUE: In 2022, during safety monitoring of FDA Adverse Event Reporting System (FAERS) data, FDA became aware of increased postmarketing adverse event …

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Published on February 27, 2023 - 20:07 GMT

Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration- Letter to Health Care Providers

February 27, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta Valve and the Trifecta Valve with …

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Published on February 27, 2023 - 16:10 GMT

ACTUALIZACIÓN: Uso del Dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicado de seguridad de la FDA

English ACTUALIZACIÓN - 27 de febrero de 2023 – El 23 de febrero de 2023, la Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) autorizó el Renuvion APR Handpiece para la administración de energía de radiofrecuencia y …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 24, 2023 - 21:16 GMT

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial ...

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 23, 2023 - 18:14 GMT

2023 Letters to Health Care Providers

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Published on February 23, 2023 - 18:14 GMT

Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers

February 23, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers and facilities about the potential for exposure to airborne chemicals that may be released from neonatal incubators. The FDA is evaluating published literature …

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Published on February 21, 2023 - 23:14 GMT

nanoMaterials Discovery Corporation Issues Voluntary Nationwide Recall of its Alcohol Antiseptic 80% Alcohol Solution

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 16, 2023 - 21:38 GMT

Philips Respironics Recalls Certain Reworked Philips Respironics Trilogy 100/200 and Garbin Ventilators Due to Potential for ...

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: Philips Respironics Trilogy 100, Trilogy 200, and Garbin Plus ventilators Product …

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Published on February 15, 2023 - 20:55 GMT

GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems for Risk of Detector Fall That May Injure Patients

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: Nuclear Medicine 600/800 Series systems Product Models: Brivo 615 Discovery NM 630 …

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Published on February 14, 2023 - 01:03 GMT

Volt Candy Issues Voluntary Nationwide Recall of PrimeZen Black 6000 Capsules Due to Presence of Sildenafil and 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 …

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Published on February 10, 2023 - 21:03 GMT

Universal Meditech Inc. Issues Nationwide Recall of Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit

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 10, 2023 - 19:33 GMT

Hospira, Inc. Issues a Voluntary Nationwide Recall for 4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl ...

Summary Company Announcement Date: October 02, 2023 FDA Publish Date: October 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Glass Particulates Company Name: Hospira, Inc. Brand Name: Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 10, 2023 - 14:20 GMT

Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray Products 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry