Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
28,992 detailed records are currently available in this category.
After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated…
Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels…
Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the…
After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated…
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients…
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated…
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device…
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device…
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device…
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio¿2 PT/INR Test Strips. This action is being initiated as a result of patients who had a therapeutic or…
Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport…
The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one…
The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required.
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
The batteries have the potential to overheating, melt or char.
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device…
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
