Loading...
Loading...
Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit
Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.
Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.
There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.
Monaco is using the incorrect energy when optimizing and calculating dose.
There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.
The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.
There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.
The products are labeled as Class II lasers. However, the level of laser radiation emitted by the distributed products may exceed the limit (1 mW) established for Class II lasers. These products would be more appropriately classified into laser Class IIIa (IEC Laser Class IIIR).
There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
A component used within the side rail mechanism may malfunction, resulting in the side rail either not locking properly in the upper position or the side rail becoming stuck in the upper position.