All recalls8,424 total
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Sterile wound dressing, lacks sterility assurance
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.
Potential contamination with lead.
Firm observed oily and sticky substance on direct food contact surface packaging of finished product.
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Foreign material (Glass) was found in the product.
Plain salt was labeled as iodized and iodized salt was labeled as plain.
Imported Enoki Mushrooms samples collected by Florida Department of Health tested positive for Listeria Monocytogenes.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Failed Impurities/Degradations Specifications
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Un-eviscerated fish may be contaminated with clostridium botulinum
Undeclared allergens: Milk and Soy
Undeclared Allergen (Soy)
Due to 11 volt Backup Battery failures.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Due to 11 volt Backup Battery failures.
Due to 11 volt Backup Battery failures.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels.
Potential contamination with foreign objects (metal pieces).
Potential contamination with foreign objects (metal pieces).
Potential contamination with foreign objects (metal pieces).
Potential contamination with foreign objects (metal pieces).
Potential contamination with foreign objects (metal pieces).