🏥 Medical Devices • 15,203 recalls
FUJIFILM Healthcare Americas
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
Qiagen Sciences
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.
ICU Medical
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
FUJIFILM Healthcare Americas
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
Mako Surgical
Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Stradis Healthcare
Potential for incomplete seals.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Ortho-Clinical Diagnostics
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
Medline Industries
Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.