FDA Press Releases - EIN Presswire - Press Release Distribution Service

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

Published on April 26, 2023 - 18:48 GMT

Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown

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 April 21, 2023 - 13:13 GMT

Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics for Risk of Inadequate ...

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 Device Use The manifold of the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics is used …

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Published on April 19, 2023 - 14:30 GMT

Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment

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: Ivenix Infusion System Model: LVP-0004 Devices Recalled in the U.S.: 1,546 Dates …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 13, 2023 - 19:46 GMT

All Opioid Pain Medicines: Drug Safety Communication - FDA Updates Prescribing Information to Provide Additional Guidance for Safe ...

[Posted 04/13/2023] AUDIENCE: Patient, Health Professional, Pain Management, Pharmacy, Caregivers  ISSUE: The FDA is requiring several updates to the prescribing information for both immediate-release (IR) and extended release/long acting (ER/LA) opioid …

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Published on April 12, 2023 - 17:20 GMT

Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety ...

Date Issued: April 12, 2023 The U.S. Food and Drug Administration (FDA) is recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2023 - 14:39 GMT

Dräger Issues Worldwide Voluntary Recall Notification for Carina Sub-Acute Care Ventilators to Address Possible Contamination of ...

Summary Company Announcement Date: August 01, 2023 FDA Publish Date: August 04, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product Safety/Potential Foreign Material Company Name: Drägerwerk AG & Co. KGaA Brand …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 7, 2023 - 14:29 GMT

Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate 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: Philips Respironics DreamStation1 (Uno Remediated Devices) Product Models: REP …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 6, 2023 - 20:09 GMT

Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring ...

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: FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 6, 2023 - 17:11 GMT

Actualización sobre reportes de carcinoma de células escamosas en la cápsula alrededor de los implantes de seno: Comunicado de ...

English Fecha de publicación: 8 de marzo de 2023 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está proporcionando una actualización sobre los reportes de carcinoma de células escamosas (SCC, por sus siglas en …

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Published on April 5, 2023 - 17:59 GMT

UPDATED: Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical 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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