Distal tip may become separated from the lumen wire in specific lots.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.
Siemens Healthcare Diagnostics
Class I - Dangerous
Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text states that the comma (,) is not used for the decimal on the PDM, when in fact it is the period (.) that is not used.If a user were to use the period as a decimal separator when entering a bolus value, this decimal separator would not be recognized by the device and any numbers entered after the period could result in a larger value than intended
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
Medtronic Vascular
Class I - Dangerous
Sterility may be compromised due to an unsealed pouch
Class I - Dangerous
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.
Getinge Group Logistics America
Class I - Dangerous
Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the Flow i Anesthesia machine.
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
System INFX-8000C
Canon Medical System, USA
Class I - Dangerous
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Medtronic Vascular
Class I - Dangerous
Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.