All recalls8,500 total
Contains undeclared allergen (shrimp).
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
Due to catheter separation
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
Product tested positive for Salmonella
Potential for Salmonella
Undeclared Tree Nut Allergen
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Failed Stability Specifications
Lack of Assurance of Sterility
Potential for Salmonella
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.