Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 58 recalls
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Due to damage to outer tray that can potentially compromise the sterile barrier
due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt pos…
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use.…