Complete FDA and NHTSA recall records dated in 2019, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the…
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan…
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the…
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the…
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan…
may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
There is an error in the chromomap on the package insert.
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan…
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
