Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 473 recalls
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, pote…
This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, i…
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire).…
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx.…
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication betwee…