FDA Press Releases

• Published on August 23, 2024 - 18:29 GMT

  

  Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient ...

  This recall involves updating instructions for using the ClotTriever XL, 30mm device, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type.  Affected Product Product Names: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 23, 2024 - 15:21 GMT

  

  Convenience Kit Component Recall: Medline Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May Be ...

  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 What to Do Do not use …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 22, 2024 - 17:08 GMT

  

  Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping ...

  This recall involves updating instructions for using certain 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 August 20, 2024 - 18:15 GMT

  

  Infusion Pump Battery Correction: ICU Medical Updates Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion ...

  This recall involves updating instructions for using certain 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 August 13, 2024 - 02:37 GMT

  

  Tandem Diabetes Care Provides Update on March 2024 Nationwide Recall of t:connect Mobile App for iOS Devices

  Summary Company Announcement Date: August 12, 2024 FDA Publish Date: August 12, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Rapid Depletion of a User’s t:slim X2 Insulin Pump Battery Company Name: Tandem Diabetes …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 12, 2024 - 18:51 GMT

  

  Heart Pump Recall: Abiomed Removes Certain Impella CP with SmartAssist Systems due to Failed Quality Inspections

  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 Name: Abiomed …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 9, 2024 - 21:23 GMT

  

  Breas Medical Issues Voluntary U.S. Nationwide Urgent Medical Device Correction of Vivo 45 LS Ventilator

  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 August 8, 2024 - 22:54 GMT

  

  B. Braun Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 Containers 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 July 31, 2024 - 18:56 GMT

  

  Abbott Issues Voluntary Medical Device Correction for a Small Number of FreeStyle Libre® 3 Sensors in the U.S.

  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 July 31, 2024 - 18:14 GMT

  

  Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes - Letter to Health Care Providers

  July 31, 2024 The U.S. Food and Drug Administration (FDA), together with Health Canada, is raising awareness among health care providers and facilities about the safe use of Mega 2000 and Mega Soft Patient Return Electrodes by Megadyne Medical Products, …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 24, 2024 - 14:39 GMT

  

  Aurobindo Pharma USA, Inc. on Behalf of AuroHealth, Issues Voluntary Nationwide Recall of one (1) Lot of Healthy Living Over the ...

  Summary Company Announcement Date: July 18, 2024 FDA Publish Date: July 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety - Mislabeling Company Name: Aurobindo Pharma USA, Inc. Brand Name: Brand Name(s …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 22, 2024 - 23:53 GMT

  

  Main Products, Inc. Issues Voluntary Nationwide Recall of Umary Acido Hialuronico, Suplemento Alimenticio Due to the Presence of ...

  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 July 22, 2024 - 21:59 GMT

  

  Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of One Lot of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) ...

  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 July 17, 2024 - 14:15 GMT

  

  Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number ...

  Summary Company Announcement Date: July 16, 2024 FDA Publish Date: July 17, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeled with the incorrect strength on the carton Company Name: Endo USA, Inc Brand Name: Brand Name( …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 17, 2024 - 00:04 GMT

  

  GURU INC. Issues Voluntary Nationwide Recall of Infla-650 Herbal Dietary Supplement Capsules Due to Hidden Drug Ingredients

  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 July 16, 2024 - 14:28 GMT

  

  Baxter Issues Urgent Medical Device Recall for Volar System Single-Patient Use Circuit

  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 July 15, 2024 - 22:48 GMT

  

  SoloVital.com Issues Voluntary Nationwide Recall of Umary Acido Hialuronica, Suplemento Alimenticio 850 mg 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 July 15, 2024 - 19:50 GMT

  

  Eye Injection Kit Recall: Bausch + Lomb/Synergetics Inc. Removes Certain I-Pack Injection Kits Due to Potential Non-Sterility

  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 (Include the following …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 15, 2024 - 16:32 GMT

  

  Ventilator Recall: Baxter Removes Life2000 Ventilator Due to Potential Failure of Battery Charging Dongle

  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 Name: Life2000 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 11, 2024 - 15:21 GMT

  

  Ventilator Software Correction: Hamilton Medical Issues Correction for HAMILTON-C6 Medical Ventilators to Address Risk of Failed ...

  This recall involves correcting certain 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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry