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....

Class 1 Recall: Zimmer Biomet Recalls Implantable Spinal Fusion...

Class 1 Recall: Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators Due to Potential of Harmful Chemicals Which May Be Toxic to Tissues and Organs
Wed May 31 2017

Zimmer Biomet is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals....

Class 1 Recall: Magellan Diagnostics Inc. Recalls LeadCare Plus and...

Class 1 Recall: Magellan Diagnostics Inc. Recalls LeadCare Plus and Ultra Testing Systems Due to Inaccurate Test Results
Fri May 26 2017

Magellan Diagnostics is recalling the LeadCare Plus and the LeadCare Ultra Testing Systems because they may underestimate the blood lead levels (BLL) and give inaccurate results when processing venous blood samples....

Class 1 Recall: Abbott Vascular Recalls Coronary Catheters Due to...

Class 1 Recall: Abbott Vascular Recalls Coronary Catheters Due to Risks Stemming from Difficulty Removing Balloon Sheath
Wed May 24 2017

Abbott has initiated a recall of specific lots of three catheters due to 19 reports of injury, and 1 report of death associated with difficulty removing the protective balloon sheath, resulting in issues with inflating or deflating the balloon....