Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 52 recalls
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, a…
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Measles IgM Test Kit lacks premarket approval or clearance.
Due to out of the box wobble of the driver.
An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acui…
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,