FDA Press Releases

• Published on May 22, 2024 - 18:31 GMT

  

  Hospira Inc. Issues A Voluntary Nationwide Recall For Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol ...

  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 May 15, 2024 - 14:51 GMT

  

  Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System ...

  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  Product Name: HeartMate 3 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 13, 2024 - 14:31 GMT

  

  Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction

  Please be aware, this recall is a correction, not a product removal. Philips Respironics is providing a software update for its Trilogy Evo continuous ventilators. The FDA has identified this as a Class I recall, the most serious type of recall. Use of …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 11, 2024 - 14:15 GMT

  

  Boulla LLC Issues Voluntary Nationwide Recall of ZoomMax and ZapMax Capsules Due to the Presence of Undeclared Sildenafil and ...

  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 May 10, 2024 - 16:24 GMT

  

  Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band

  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 Route 92 Medical catheters are used to deliver microcatheters to the blood vessels …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 10, 2024 - 15:44 GMT

  

  MEGADYNE™ Initiates Global Discontinuation and Voluntary Recall of MEGA SOFT™ Pediatric Patient Return Electrode

  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 May 10, 2024 - 04:00 GMT

  

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

  Date Issued: May 10, 2024 The U.S. Food and Drug Administration (FDA) is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests for Home and Over-the-Counter (OTC) Use and its COVID-19 Test intended for …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 9, 2024 - 19:22 GMT

  

  Safety and Quality Concerns with Getinge Cardiovascular Devices - Letter to Health Care Providers

  May 8, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet cardiovascular medical devices: Getinge/Maquet/Datascope Cardiosave …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 9, 2024 - 19:22 GMT

  

  Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin ...

  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: Version 2.7 of …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 9, 2024 - 10:42 GMT

  

  Continuous Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc Issues Recall for Certain FreeStyle Libre 3 Sensors ...

  This recall involves removing certain devices from where they are used or sold, and does not apply to the FreeStyle Libre 3 reader or app. 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 May 9, 2024 - 10:35 GMT

  

  Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in ...

  This recall involves updating instructions for using 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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 9, 2024 - 09:31 GMT

  

  Laryngoscope Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others 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.  This recall also involves updating …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 6, 2024 - 18:53 GMT

  

  HomeoCare Laboratories Inc. Issues Voluntary Nationwide Recall of Homeopathic Stella Life Oral Care Spray Unflavored and Advanced ...

  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 May 6, 2024 - 11:00 GMT

  

  Medtronic Recalls StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 for Software Error that May Cause ...

  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: StealthStation …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 30, 2024 - 15:32 GMT

  

  BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations

  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: VITEK 2 AST …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 29, 2024 - 16:21 GMT

  

  SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm ...

  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: SonarMed Airway monitors  Product Codes: OQU  Model Numbers: AW-M0001 Distribution …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 29, 2024 - 16:21 GMT

  

  SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage ...

  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 SonarMed airway monitoring system (AMS) is comprised of a SonarMed monitor ( …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on April 26, 2024 - 17:39 GMT

  

  Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic ...

  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: Disposable Biopsy Needles (911933) Product Codes: HAW Lot Number: 837838839 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• 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