Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 7981–8000 of 38,428 recalls
Recalled Item: Medtronic ILLUMISITE Platform Console
The Issue: Single ILLUMISITE Platform Console was converted from a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemospray Endoscopic Hemostat: Part Numbers: a) HEMO-10
The Issue: There are potential risks of the Hemospray powder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemospray Endoscopic Hemostat: Part Numbers: a) HEMO-7
The Issue: There are potential risks of the Hemospray powder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UroPass Ureteral Access Sheaths
The Issue: Dilator tips may break in the package and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruSignal Integrated Ear Sensor with Datex Connector
The Issue: There is a potential reduction of energy reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for
The Issue: Identified a decreased performance reliability rate, Run abortions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2
The Issue: Identified a decreased performance reliability rate, Run abortions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contour¿ next GEN Blood Glucose Monitoring System
The Issue: Ascensia Diabetes Care has determined through customer complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Precoat Stemmed Tibial Plate Size 5
The Issue: Device outer packaging was incorrectly labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruSignal Sensitive Skin Sensor
The Issue: There is a potential reduction of energy reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruSignal AllFit Sensor: a)
The Issue: There is a potential reduction of energy reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruSignal Integrated Ear Sensor with Ohmeda Connector
The Issue: There is a potential reduction of energy reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe OmniBed Carestation CS1
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruSignal Adult/Pediatric Sensor
The Issue: There is a potential reduction of energy reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beside panel FRU (Field Replacement Units) Kits
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruSignal Wrap Sensor
The Issue: There is a potential reduction of energy reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruSignal Integrated Ear Sensor with Datex Connector
The Issue: There is a potential reduction of energy reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruSignal Integrated Ear Sensor with GE Connector
The Issue: There is a potential reduction of energy reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe OmniBed
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruSignal Ear Sensor
The Issue: There is a potential reduction of energy reaching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.