95,025 total recalls in our database
Preferred Pharmaceuticals
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Teva Pharmaceuticals USA
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Preferred Pharmaceuticals
Out of specification results observed in dissolution during long term stability testing.
Preferred Pharmaceuticals
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Aurobindo Pharma USA
Subpotent Drug: Out of Specification results for Assay
GE Healthcare
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.
Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.
Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients treated with the Liposorber LA-15 LDL Adsorption Column under concomitant ACE inhibitor medication treatment.
Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Philips North America
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
Boston Scientific
Pouch seals may be open, compromising sterility.
Abbott Vascular
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Conformis
Incorrect tibial base plate implant packaged in kit
Boston Scientific
Pouch seals may be open, compromising sterility.
Cardinal Health 200
Product was distributed without being sterilized.
Nextremity Solutions
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery