FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on January 19, 2024 - 17:19 GMT

Prolia (denosumab): Drug Safety Communication - FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with ...

[Posted 01/19/2024] AUDIENCE: Patient, Health Professional, Endocrinology, Nephrology, Pharmacy ISSUE: Based on a completed FDA review of available information, FDA has concluded that the osteoporosis medicine Prolia (denosumab) increases the risk of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 18, 2024 - 18:17 GMT

Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical ...

Date Issued: January 18, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about AirFit and AirTouch mask models recalled by ResMed Ltd (ResMed). These masks are used with bilevel positive airway …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 16, 2024 - 20:08 GMT

Risks with Exactech Equinoxe Shoulder System with Defective Packaging - FDA Safety Communication

314-01-02 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Small 10885862084408 314-01-03 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Medium 10885862084415 314-01-04 GLENOID,KEELED, CEMENTED,Mates with 38, 41, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 16, 2024 - 19:37 GMT

ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility

Please be aware, this recall is a correction, not a product removal. 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: Regard …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 12, 2024 - 17:44 GMT

Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference

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: Ivenix Large Volume Pump Product Codes: FRN Model Numbers: LVP-0004 Distribution …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2024 - 21:02 GMT

ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with ...

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 correction, not a product removal. Recalled Product Device Use The AirFit and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2024 - 20:16 GMT

Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist

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 Busse tracheostomy care trays and kits come sterile packaged and include commonly …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2024 - 16:28 GMT

Certain Type of Medicines Approved for Type 2 Diabetes and Obesity: Drug Safety Communication - Update on FDA’s Ongoing Evaluation ...

[Posted 01/11/2024] AUDIENCE: Patient, Health Professional, Endocrinology, Pharmacy ISSUE: The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2024 - 10:39 GMT

IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Phasitron …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 10, 2024 - 12:45 GMT

Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy ...

This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 10, 2024 - 11:41 GMT

Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) ...

This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 9, 2024 - 16:30 GMT

2024 Letters to Health Care Providers

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.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 9, 2024 - 16:15 GMT

Potential Exposure to Certain Chemicals with Use of GE HealthCare EVair and EVair03 Compressors with Certain Ventilators – Letter ...

January 9, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about the potential for exposure to certain chemicals that may be released when General Electric (GE) HealthCare accessory components called the …

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Published on January 8, 2024 - 19:24 GMT

Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns

Please be aware, this recall is a correction, not a product removal. 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 Mega Soft …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 8, 2024 - 19:24 GMT

Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags 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 January 8, 2024 - 17:53 GMT

2024 Medical Device Recalls

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 8, 2024 - 17:53 GMT

Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error

Please be aware, this recall is a correction, not a product removal. 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: Omnipod 5 …

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Published on January 6, 2024 - 08:12 GMT

Medline Industries, LP Issues Nationwide Recall of SubG Endotracheal Tube with Subglottic Suction

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 January 5, 2024 - 15:16 GMT

Getinge / Atrium Medical Corporation Issues Medical Device Correction for Nurse Assist Syringes Provided with Express Drains

Summary Company Announcement Date: January 03, 2024 FDA Publish Date: January 04, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Syringes provided with Express Drains could not be verified to be sterile. Company Name: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 4, 2024 - 18:15 GMT

AvKARE, LLC. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5 mL Due to Potential Bacillus Cereus ...

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