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.
25,099 detailed records are currently available in this category.
Distributed to the field without having completed design history files or design transfer activities
Distributed to the field without having completed design history files or design transfer activities
Distributed to the field without having completed design history files or design transfer activities
Distributed to the field without having completed design history files or design transfer activities
Under certain conditions, a marble pattern infrequently appears on the monitor.
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Under certain conditions, a marble pattern infrequently appears on the monitor.
Distributed to the field without having completed design history files or design transfer activities
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.
Distributed to the field without having completed design history files or design transfer activities
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.
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
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.
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.
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.
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.
