Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 493–504 of 634 recalls
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device.…
Potential for the presence of visible foreign matter.
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
A cybersecurity vulnerability was discovered through internal testing.
A cybersecurity vulnerability was discovered through internal testing.
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Inadequate weld that can potentially cause the product to disassemble.
Inadequate weld that can potentially cause the product to disassemble.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.