All recalls8,501 total
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.
Assayed Whole blood control contains labeling with incorrect performance range.
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Due to an increase rate of balloon pinhole defects.
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Reusable electrodes may not meet expected performance levels.
Sterile anchors my lack sterility assurance.
Reusable electrodes may not meet expected performance levels.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
Potential presence of Salmonella.
Potential presence of Salmonella.
Potential presence of Salmonella.
Potential presence of Salmonella.
Potential presence of Salmonella.
Products contain undeclared soy, specifically soy lecithin.
Potential presence of Salmonella.
Clostridium botulinum is an uncontrolled hazard
Presence of Particulate Matter.
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
A single lot of expired syringes were distributed due to a distribution system control failure.
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.