FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on March 11, 2024 - 20:01 GMT

Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop

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: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 11, 2024 - 16:05 GMT

Windstone Medical Packaging, Inc. Recalls Local Lower Extremity Pack, In House Ocular Pack and Closure Kit Containing Sterile ...

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 Windstone …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 7, 2024 - 21:04 GMT

Cardinal Health Recalls Sterile Monoject Luer-Lock and Enteral Syringes Due to a Change in Manufacturing

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 Cardinal Health Monoject disposable syringes are used to inject fluid into or withdraw …

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Published on March 7, 2024 - 19:56 GMT

Ventec Life Systems Recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded ...

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: VOCSN Patient …

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Published on March 7, 2024 - 17:35 GMT

Medtronic Neurosurgery Recalls Duet External Drainage and Monitoring System Catheter Tubing due to a Potential for the Catheter ...

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 DUET External Drainage and Monitoring System (EDMS) is used for temporary drainage …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 6, 2024 - 19:29 GMT

Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 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 Device Use The ExactaMix Pro …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 5, 2024 - 21:43 GMT

Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions

Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: Medfusion syringe pump Product Codes: FRN Model Numbers: Model 3500 syringe pump Distribution Dates: August 9, 2002 to August 15, 2023 Devices Recalled in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 4, 2024 - 09:55 GMT

Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits 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: ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 29, 2024 - 20:21 GMT

Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication

Date Issued: February 29, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about a higher-than-expected risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 29, 2024 - 19:57 GMT

Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door ...

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: Care Plus, …

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Published on February 29, 2024 - 19:32 GMT

Megadyne Reiterates Intended Use Population Change for Megadyne Mega Soft Universal and Universal Plus Patient Return Electrodes

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 February 29, 2024 - 18:24 GMT

Follow Instructions for Safe Use of Electrical Operating Room Tables - Letter to Health Care Providers

February 29, 2024 The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers and facilities about the safe use of electrical operating room tables. The FDA has received reports of adverse events associated with electrical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 27, 2024 - 20:14 GMT

BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication

Date Issued: February 27, 2024 The U.S. Food and Drug Administration (FDA) is informing patients and health care providers about the potential risk of serious complications with the use of BioZorb Marker and BioZorb LP Marker devices by Hologic, Inc. The …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 27, 2024 - 19:11 GMT

Avanos Medical, Inc. Announces Voluntary Recall in Response to Nurse Assist, LLC Sterile Water Medical Products Recall

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 February 26, 2024 - 17:11 GMT

Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, ...

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 February 21, 2024 - 20:26 GMT

Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication

Date Issued: February 21, 2024 The U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 15, 2024 - 16:54 GMT

Philips Recalls BrightView Imaging Systems Due to the Detector Unexpectedly Falling

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: BrightView, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 14, 2024 - 17:44 GMT

Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software Versions

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: Medfusion …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 10, 2024 - 12:01 GMT

IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental ...

This recall involves updating instructions for using these 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 6, 2024 - 18:51 GMT

Percussionaire Recalls High Frequency Transport Phasitron Breathing Circuit Kits for Over-Pressurization

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: High Frequency Transport Phasitron Breathing Circuit Kit (A50605-D) Product Codes: …

Distribution channels: Healthcare & Pharmaceuticals Industry