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: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Product Models: Distribution Dates: March 6, 2012 to May 19, 2023 Devices…
Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots
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: Impella RP Flex with SmartAssist Product Codes: See Recall Database Entry Model…
Philips Respironics Recalls Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators After Finding Dust and Dirt in Air Path That Can Reduce Air Flow to Patients
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: Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal Product Models and Serial Numbers: See Medical Device Recall Database Distribution Dates: March…
Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety Communication
Date Issued: August 11, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers and patients to not use the following tests manufactured by Universal Meditech, Inc. (UMI): One Step Pregnancy Test DiagnosUS One Step Ovulation Test HealthyWiser UriTest 10 Parameter Reagent Test Strips for Urinalysis HealthyWiser UriTest UTI Test Strips HealthyWiser KetoFast Ketone…
Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns
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 Recalled Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Product Models: Distribution Dates: March 6, 2012 to May 19, 2023 Devices…
Dräger Issues Worldwide Voluntary Recall Notification for Carina Sub-Acute Care Ventilators to Address Possible Contamination of the Breathing Gas with 1,3-Dichloropropan-2-ol
Summary Company Announcement Date: August 01, 2023 FDA Publish Date: August 04, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product Safety/Potential Foreign Material Company Name: Drägerwerk AG & Co. KGaA Brand Name: Brand Name(s) Product Description: Product Description Carina Sub-Acute Care Ventilators Company Announcement Drägerwerk AG & Co. KGaA initiated a…
Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results at the 12-month Stability Time Point
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…