95,025 total recalls in our database
An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.
Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The instructions for use rely on these checks rather than specifying a maximum number of sterilization cycles to determine when the paddles should be discarded. A damaged Internal Paddle may not be able to deliver therapy.
Medtronic Vascular Galway
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
GE Healthcare
During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
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.
Potential presence of elevated endotoxin levels that exceed the specification limit
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 Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
Potential presence of elevated endotoxin levels that exceed the specification limit
Potential presence of elevated endotoxin levels that exceed the specification limit
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
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 "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 analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.
Philips North America
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Sonendo
The console would continue to run for extended period when the foot pedal was released.
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.
Siemens Medical Solutions USA
The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.