Summary Company Announcement Date: July 29, 2023 FDA Publish Date: July 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Out of Specification Results Company Name: Lupin Pharmaceuticals, Inc. Brand Name: Brand Name(s) Lupin Pharmaceuticals, Inc. Product Description: Product Description Tydemy oral contraceptive Company Announcement Baltimore, Maryland, July 28, 2023: Lupin Pharmaceuticals Inc….
Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with Dose IQ Safety Software for Repeat Upstream Occlusion False Alarms
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: SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) Product Codes: 35700BAX2…
Baxter Issues Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ Infusion Pumps with Specific Software Versions
Summary Company Announcement Date: July 28, 2023 FDA Publish Date: July 31, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to an increase in reported false upstream occlusion alarms following the software upgrades. Company Name: Baxter International Inc. Brand Name: Brand Name(s) SIGMA Spectrum and Spectrum IQ Product Description: Product Description…
GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings
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…
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:…