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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Due to complaints, software update may cause software to unexpectedly shutdown.
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%