Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 877–888 of 1,121 recalls
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device.…
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.