Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Incorrect priming volume printed on the device package.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
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…
Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
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…
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…
Software updates
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.
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.
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
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.
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.
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
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…
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…
Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.
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…
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…
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Browse recent months with enough recall history for useful comparison.
