Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,453–1,464 of 2,088 recalls
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or h…
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr…
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr…
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.