Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 337–348 of 348 recalls
Inflation device handle may detach from the syringe during procedure.
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear;…
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended.…
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Butyrate tube cracks during actuation, rendering product unusable.