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.
25,676 detailed records are currently available in this category.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the…
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer…
Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the…
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the…
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the…
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
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.
