FDA Alerts

Class 1 Recall: Becton Dickinson (BD) and Company Recalls Vacutainer®...

Class 1 Recall: Becton Dickinson (BD) and Company Recalls Vacutainer® EDTA Blood Collection Tubes Due to Chemical Interference with Certain Tests
Fri Mar 23 2018

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....

Class 1 Recall: Monteris Medical NeuroBlate System Recalled Due to...

Class 1 Recall: Monteris Medical NeuroBlate System Recalled Due to Unexpected Heating of Laser Delivery Probes
Thu Mar 22 2018

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...

Class 1 Recall: Medtronic Recalls Cardiac Resynchronization Therapy...

Class 1 Recall: Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery
Mon Feb 26 2018

Recalled Product(s): Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs)...

Class 1 Recall: Philips Electronics Recalls HeartStart MRx...

Class 1 Recall: Philips Electronics Recalls HeartStart MRx Defibrillator Due to Defects in Gas Discharge Tubes Which May Cause Device Failure
Mon Feb 12 2018

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....

Class 1 Recall: Vyaire Medical Recalls AirLife Humidification Chamber...

Class 1 Recall: Vyaire Medical Recalls AirLife Humidification Chamber & Heated Breathing Circuit Kits Due to Manufacturing Error
Tue Jan 30 2018

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....

Class 1 Recall: Edwards Lifesciences LLC. Recalls Certitude Delivery...

Class 1 Recall: Edwards Lifesciences LLC. Recalls Certitude Delivery System Due to Mold Overflow Defect Which May Obstruct Blood Flow
Thu Jan 11 2018

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....

Class 1 Recall: Physio-Control Inc. Recalls Defibrillation Electrodes...

Class 1 Recall: Physio-Control Inc. Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork
Tue Dec 19 2017

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....

Class 1 Recall: Datascope Corp./MAQUET Recalls Intra-Aortic Balloon...

Class 1 Recall: Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to Risk of Valve Failure Preventing Balloon Inflation and Deflation
Mon Aug 07 2017

Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps manufactured before June 30, 2013 due to the risk of a valve failure which prevents the balloon from inflating and deflating properly....

Class 1 Recall: Updated Status of FUJIFILM Medical Systems, U.S.A.,...

Class 1 Recall: Updated Status of FUJIFILM Medical Systems, U.S.A., Inc. Model ED-530XT Duodenoscopes: FDA Safety Communication
Thu Jul 27 2017

The FDA is issuing this communication to provide updated status information about FDA clearance of Fujifilm's ED-530XT and to amplify Fujifilm's Urgent Medical Device Correction and Removal notice, issued on July 21, 2017....

Class 1 Recall: Navigational Accuracy Errors Associated with...

Class 1 Recall: Navigational Accuracy Errors Associated with Frameless Stereotaxic Navigation Systems: FDA Safety Communication
Thu Jun 15 2017

The FDA is aware that some health care providers have experienced navigational accuracy errors during surgical procedures when using frameless stereotaxic navigation systems....