🏥 Medical Devices • 7,015 recalls
ROi CPS
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions for Use ("IFU").
Baxter Healthcare
ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
Merit Medical Systems
Product that was built for design verification testing was inadvertently distributed to customers.
Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
The incorrect IFU was distributed with the devices.
Sterility; Steril surgical procedure packs contain incomplete seals.
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.
Becton Dickinson & Company
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
Becton Dickinson & Company
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.
Becton Dickinson & Company
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
Becton Dickinson & Company
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.