FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on April 25, 2024 - 14:15 GMT

Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of ...

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: Tablo Hemodialysis Device Product Codes: See Recall Database Entry Devices Recalled …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 25, 2024 - 14:15 GMT

InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and ...

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 Nimbus Administration Set, Flex, and PainPro, also known as the Halo Ambulatory …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 25, 2024 - 14:15 GMT

Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to ...

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 Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter are indicated for use …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 25, 2024 - 14:15 GMT

Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power

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 Name: Perseus A500 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 24, 2024 - 14:52 GMT

DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley 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 Product Names: GeoMed Custom Tracecarts Product Codes: LRO Model Numbers: 53-1829 Laminectomy …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 23, 2024 - 18:51 GMT

Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency

Summary Company Announcement Date: April 23, 2024 FDA Publish Date: April 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Decreased Potency Company Name: Dr. Reddy’s Laboratories Inc Brand Name: Brand Name(s) Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 23, 2024 - 15:45 GMT

STOP CLOPEZ CORP Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil

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 22, 2024 - 13:15 GMT

FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication

Date Issued: April 22, 2024 The U.S. Food and Drug Administration (FDA) encourages the public to follow established choking rescue protocols, which are step-by-step guides, approved by the American Red Cross and the American Heart Association to relieve …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 17, 2024 - 21:12 GMT

Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient ...

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: LVP Software of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 17, 2024 - 18:00 GMT

Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding

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 Name: Obsidio …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 15, 2024 - 15:13 GMT

Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing ...

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 HeartMate II …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 12, 2024 - 10:28 GMT

Syringe Recall: Cardinal Health Removes Certain Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs due to ...

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: Monoject U …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 9, 2024 - 18:01 GMT

Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue with Certain Bivona® ...

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 April 9, 2024 - 10:08 GMT

Lung Therapy Component Recall: Baxter Healthcare Corporation Recalls Certain Volara System Single-Patient Use Circuits and Blue ...

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 Figure 1: Volara system …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2024 - 23:04 GMT

Medline Industries, LP Issues a Nationwide Recall of Convenience Kits Containing Nurse Assist 0.9% Sodium Chloride Irrigation USP ...

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 April 5, 2024 - 18:23 GMT

Aruba Aloe Balm N.V. Issues Voluntary Nationwide Recall of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel ...

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 5, 2024 - 13:10 GMT

Honeywell Safety Products USA, Inc. Issues Voluntary Worldwide Recall of Honeywell Fendall 2000 Non-Sterile Eyewash Cartridges # ...

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 April 4, 2024 - 14:39 GMT

Medos International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft

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: CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: GS9070SD; GS9080SD; …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 4, 2024 - 14:19 GMT

Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator Kits for a Malfunction Causing Non-Cycling, Continuous ...

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 Smiths Medical ASD …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 28, 2024 - 13:30 GMT

Eugia US LLC (f/k/a AuroMedics Pharma LLC) Issues Voluntary Nationwide Recall of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/...

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