Complete FDA and NHTSA recall records dated in May 2024.
These records include useful source details for the selected month.
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…
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
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.
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.
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…
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
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the…
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…
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
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
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not…
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…
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not…
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
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
Product was distributed in the United States without proper regulatory approval.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
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.
