FDA Press Releases

• Published on October 25, 2024 - 18:09 GMT

  

  Assistive Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic Arm due to Fire Hazard and Burn Risk

  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 October 25, 2024 - 17:12 GMT

  

  Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication

  Español 简体中文 (Simplified Chinese) Tagalog Date Issued: October 25, 2024 The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and health care facilities not to use BioZorb Markers and BioZorb LP Markers (hereafter …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 25, 2024 - 16:11 GMT

  

  Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential ...

  BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX 101/800/060CZ 3895097 3925835 4025600 4106716 4230149 4252500 4382002 BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX 101/800/070CZ 3895101 3925960 3933088 4010050 4022790 4034826 4037975 4133612 4152440 4156971 4217804 4238237 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 19, 2024 - 01:35 GMT

  

  Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

  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 October 18, 2024 - 19:17 GMT

  

  Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased ...

  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 October 16, 2024 - 04:00 GMT

  

  UPDATE: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication

  Español 简体中文 (Simplified Chinese) Tagalog Update: October 16, 2024 The FDA has classified Cue Health’s recall of their two COVID-19 tests as Class II. FDA has also revoked the Emergency Use Authorization (EUA) for Cue Health’s two COVID-19 tests. …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 16, 2024 - 04:00 GMT

  

  C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug ...

  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 16, 2024 - 04:00 GMT

  

  Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-...

  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 11, 2024 - 17:08 GMT

  

  Infusion Pump Recall: Zyno Medical Removes Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect ...

  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  Pump Model Unique …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 30, 2024 - 19:02 GMT

  

  Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume ...

  Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement    This recall involves correcting devices, and does not involve removing them from where they are used or sold …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 24, 2024 - 14:00 GMT

  Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding ...

  Automated Compounding Device Inlets used with Exactamix Compounding Devices may contain particulate matter that poses a risk to patients.

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 23, 2024 - 16:32 GMT

  

  Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a ...

  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 20, 2024 - 14:10 GMT

  

  Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector

  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: PneuPAC …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 18, 2024 - 18:52 GMT

  

  Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes 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 Image of torn flange due …

  Distribution channels:
• Published on September 18, 2024 - 18:33 GMT

  

  Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination

  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 17, 2024 - 13:36 GMT

  

  Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in ...

  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
• Published on September 17, 2024 - 13:23 GMT

  

  Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture - FDA Safety Communication

  Date Issued: September 17, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, health care providers, and health care facilities about the increased risk of thigh bone fracture after surgery (postoperative periprosthetic …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 16, 2024 - 16:47 GMT

  

  Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets

  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: Ivenix LVP …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 12, 2024 - 17:44 GMT

  

  FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. ...

  [Posted 9/12/2024] AUDIENCE: Patient, Health Professional, OBGYN, Endocrinology ISSUE: The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury.  If there are signs and …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• 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