FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on October 20, 2023 - 16:37 GMT

Philips Respironics Recalls V60 and V60 Plus Ventilators due to Power Management Printed Circuit Board Assemblies (PM PCBAs) Not ...

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.  Recalled Product Product Names: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 20, 2023 - 01:19 GMT

Medtronic Notification of Stolen Defective Products – Potentially Defective McGRATH™ MAC Video Laryngoscopes

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 October 18, 2023 - 14:35 GMT

Hamilton Medical Inc. Recalls HAMILTON-C1, T1, MR-1 Ventilators for Capacitator Leaks and Short Circuits

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. Recalled Product Product Names: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 10, 2023 - 18:34 GMT

Voluntary Recall of Certain Over-the-Counter Drugs and Medical Devices

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 September 29, 2023 - 15:22 GMT

Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety ...

Español September 29, 2023 The FDA is providing an update to consumers, health care providers, and facilities about certain surgical N95 respirators and masks manufactured by O&M Halyard. This update includes the current recommendations for these …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 28, 2023 - 14:46 GMT

SCYNEXIS Issues a Voluntary Nationwide Recall of BREXAFEMME® (ibrexafungerp tablets) Due to Potential for Cross Contamination with ...

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 September 22, 2023 - 23:19 GMT

VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified ...

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 September 22, 2023 - 19:27 GMT

Universal Meditech Inc. Expands Nationwide Recall to All Products Manufactured between March 2021 and November 2022

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 September 20, 2023 - 15:35 GMT

Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile

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: Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Product Codes: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 13, 2023 - 18:57 GMT

Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode

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 Abbott Proclaim neurostimulation systems delivers low-intensity electrical impulses …

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Published on September 12, 2023 - 18:11 GMT

Bone Matrix Product: FDA Safety Communication - Important Information for Human Cell, Tissue and Cellular and Tissue-based Product ...

[Posted 09/06/2023] AUDIENCE: Patient, Health Professional, Infectious Disease, Surgery, Transplantation ISSUE: FDA is working closely with the Centers for Disease Control and Prevention (CDC) to investigate recent reports of a tuberculosis (TB) outbreak …

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Published on September 12, 2023 - 13:49 GMT

Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly

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: One-Way Valve, 22F x 22M Product Codes: See Recall Database Entry Model Numbers: …

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Published on September 11, 2023 - 18:16 GMT

Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL ...

Summary Company Announcement Date: September 11, 2023 FDA Publish Date: September 11, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Crystal formation which could potentially result in incorrect dosing Company Name: Novartis …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 11, 2023 - 13:02 GMT

Labeling Updates for BD Mesh Products - Letter to Health Care Providers

November 9, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about labeling updates for Becton, Dickinson and Company (BD) mesh products: Phasix Mesh Phasix ST Mesh Phasix Plug and Patch Phasix ST Mesh with Open …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 8, 2023 - 04:00 GMT

Church & Dwight Issues Voluntary Nationwide Recall of One Specific Lot of TheraBreath Strawberry Splash for Kids 16oz Sold ...

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 August 31, 2023 - 17:11 GMT

Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Gas Loss and Gas Gain ...

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

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 31, 2023 - 17:11 GMT

Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Power Failures When Device is ...

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

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 31, 2023 - 17:11 GMT

Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Autofill Failure Alarms ...

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

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 31, 2023 - 17:10 GMT

Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature ...

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

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 31, 2023 - 17:10 GMT

UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) – Letter to Health Care ...

August 31, 2023 The U.S. Food and Drug Administration (FDA) is providing an update about device failures for Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices. The FDA is issuing this letter to help ensure …

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