Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 85–96 of 218 recalls
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between…
Resorbable bone void filler falls outside standard specifications.
Resorbable bone void filler falls outside standard specifications.
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchron…
Cyber vulnerability of BLE communication was found by CISA VDP program.
Cyber vulnerability of BLE communication was found by CISA VDP program.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.