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: TruSignal Adult Pediatric Sensor TruSignal AllFit Sensor TruSignal Sensitive Skin Sensor TruSignal Wrap Sensor TruSignal Ear Sensor TruSignal Integrated Ear Sensor with GE Connector TruSignal…
Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent
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 voluntary correction, not a product removal. Recalled Product Product Names and Product Codes: Impella 5.0 Blood Pump, Product Number 005062 Impella CP…
Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism
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: Amplatzer Steerable Delivery Sheath Product Model: ASDS-14F-075 Distribution Dates: October 4, 2022 to February 22, 2023 Devices Recalled in the U.S.: 672 Date Initiated by…
Contact Lenses: Safe Use of Hydrogen Peroxide Solution
Image Español If you wear contact lenses, the way you clean and disinfect them can affect your vision and health. Following instructions from your eye care professional and from the contact lens solution manufacturer are especially important if you use a solution that contains hydrogen peroxide. Hydrogen Peroxide Solution Contact lens solutions are sold over…
Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication
Date Issued: July 17, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, or Well-Being Reality. The devices have not been reviewed by the FDA. The safety and effectiveness of these devices have not been established to diagnose, treat, or…
Use Alternative Testing Method for the Quidel Cardiovascular Inc. Quidel Triage Cardiac Panel – Letter to Health Care Providers
July 19, 2023 The U.S. Food and Drug Administration (FDA) is recommending health care providers, laboratory personnel, and facilities stop using the Quidel Triage Cardiac Panel, manufactured by Quidel Cardiovascular Inc. (QuidelOrtho). On May 25, 2023, QuidelOrtho issued an Urgent Product Correction Notification to customers in which they recalled certain lots of the Quidel Triage…
Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy
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: Cobalt XT, Cobalt, Crome ICDs and CRT-Ds Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds Visia AF, Visia AF MRI, Evera, Evera MRI, Primo…
Quidel Cardiovascular Inc. Recalls Quidel Triage Cardiac Panels for Risk of False Negative Troponin Results that Could Cause Delayed Diagnosis or Missed Myocardial Infarction
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: Quidel Triage Cardiac Panel Quidel Triage Cardiac Panel, Troponin I Quidel Triage Cardiac Panel, CK-MB and Troponin I Product Codes: 97000HS 97021HS 97022HS Product Lots:…
NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates
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: NOxBOXi Nitric Oxide Delivery System Product Serial Numbers: See Recall Database Entry Distribution Dates: May 21, 2021 to February 27, 2023 Devices Recalled in the…
FDA D.I.S.C.O. Burst Edition: FDA approval of Lynparza (olaparib), with abiraterone and prednisone, for BRCA-mutated metastatic castration-resistant prostate cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On May 31, 2023, the FDA approved olaparib (brand name…