Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,309–1,320 of 1,678 recalls
Due to damage to outer tray that can potentially compromise the sterile barrier
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may r…
Potential packaging failures, which could lead to a breach in the sterile barrier.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
Issue with software algorithm which may lead to overpressure events.
Issue with software algorithm which may lead to overpressure events.
Issue with software algorithm which may lead to overpressure events.
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.