🏥 Medical Devices • 4,350 recalls
Randox Laboratories
Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
Becton, Dickinson and Company, BD Biosciences
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
Mani, Inc. - Kiyohara Facility
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
Randox Laboratories
Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
Missing solder battery connection, which could interrupt power of insulin pump.
Missing solder battery connection, which could interrupt power of insulin pump.
Due to a change in handle material and process, probe handle may crack.
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Inova Lasers
The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
Cardinal Health 200
The feeding spike sets may leak at the interface of the tube and spike connector.
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
Cardinal Health 200
The feeding spike sets may leak at the interface of the tube and spike connector.
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
Medicrea International
Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,
The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.
Boston Scientific
The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.
Due to false positive results.
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
OriGen Biomedical
The firm has become aware that they have distributed product that was expired.
The wall charger may not properly charge the infusion pump battery.