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.
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Potential for reported SSD to be too high.
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no…
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no…
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
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
Product was distributed in the United States without proper regulatory approval.
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
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
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
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
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…
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…
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.
