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.
28,065 detailed records are currently available in this category.
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could…
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could…
Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the…
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could…
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if…
Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could…
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could…
Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific…
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could…
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.
Software updates
The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved…
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could…
Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations…
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.
