🏥 Medical Devices Class I - Dangerous
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
All Recalls
95,050 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.
🏥 Medical Devices Class I - Dangerous
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
🏥 Medical Devices Class I - Dangerous
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
🏥 Medical Devices Class I - Dangerous
The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
🏥 Medical Devices Class I - Dangerous
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
🏥 Medical Devices Class I - Dangerous
Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
🏥 Medical Devices Class I - Dangerous
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
🏥 Medical Devices Class I - Dangerous
Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
🏥 Medical Devices Class I - Dangerous
The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.
🏥 Medical Devices Class I - Dangerous
The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.
🏥 Medical Devices Class I - Dangerous
The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
🏥 Medical Devices Class I - Dangerous
The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
Potential lack of sterility assurance
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Maquet Cardiovascular Us Sales
🏥 Medical Devices Class I - Dangerous
Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.
🏥 Medical Devices Class I - Dangerous
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch