Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 217–228 of 4,960 recalls
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
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…
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2.…
Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is l…
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…
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI…
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.