🏥 Medical Devices • 6,839 recalls
C.A. Greiner & Sohne Gesellschaftmbh
While transferring blood the needle may dislodged and remain in the tube stopper which may cause needle stick injury or blood leakage.
The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Medtronic Vascular Galway
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
Tungsten coils of the guidewire included in the introducer kit were detaching.
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.
The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.
The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Applied Medical Resources
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Applied Medical Resources
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Applied Medical Resources
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Becton Dickinson & Company
This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Observed an internal repetitive software glitch in ImmersiveView.