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.
22,877 detailed records are currently available in this category.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a…
Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover…
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message…
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result…
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for…
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are…
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results,…
Product demonstrates low viscosity.
Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the…
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years.
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result…
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.
