Complete FDA and NHTSA recall records dated in June 2020.
These records include useful source details for the selected month.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
A manufacturing error resulted in out of specification R3 Acetabular Shells
A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent…
The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as…
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Distributed to the field without having completed design history files or design transfer activities
There is potential for the plastic optical tip to become detached from the metal shaft.
A manufacturing error resulted in out of specification R3 Acetabular Shells
There is potential for the plastic optical tip to become detached from the metal shaft.
There is potential for the plastic optical tip to become detached from the metal shaft.
Distributed to the field without having completed design history files or design transfer activities
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Distributed to the field without having completed design history files or design transfer activities
There is potential for the plastic optical tip to become detached from the metal shaft.
There is potential for the plastic optical tip to become detached from the metal shaft.
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
There is potential for the plastic optical tip to become detached from the metal shaft.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
There is potential for the plastic optical tip to become detached from the metal shaft.
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology…
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
