All recalls8,508 total
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur in these models, whether in the field or factory, but could potentially occur under excessive force or extreme, continuous vibration.
Product contains undeclared wheat.
Contains undeclared wheat. The top label identifies the product as potato salad, but the unit contains pasta salad.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Lack of Assurance of Sterility.
Lack of Assurance of Sterility.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Potential for open header bag seals, compromising sterility.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Potential for open header bag seals, compromising sterility.
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Product contains undeclared soy lecithin.
Product contains undeclared wheat and soy.
Foreign object (metal) in granulated onion ingredient.
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity and potentially leading to surgical site infections.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Product mislabeled - cans are labeled as Zero Sugar, but contain full sugar product
Frozen Oyster product is potentially contaminated with Norovirus
Frozen Oyster product is potentially contaminated with Norovirus
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility