Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 39 recalls
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
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.…
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws…
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.