Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 73–84 of 439 recalls
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead di…
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…
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)
Due to the likely presence of contamination in well(s).
Due to product exhibiting potential to generate either invalid or false negative results.
Behind-the-ear sound processer packaging label is different then included product.
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.