All Recalls

If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning

An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.

The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.

The finished device package did not contain the IFU.

Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.

Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.

There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.

New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead to insulin under-delivery. Insulin under-delivery can cause severe hyperglycemia, which may lead to diabetic ketoacidosis. Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active. Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different.

The lithium-ion battery can overheat, posing a fire hazard.

The alarms can fail to alert consumers to the presence of a hazardous level of carbon monoxide, posing a risk of carbon monoxide poisoning or death. Carbon monoxide (CO) is an odorless, colorless, poisonous gas.

Firm is recalling Dried Plums due to potential high lead content.

Potential to contain foreign material (metal).

Undeclared Almond and Coconut in the Contains statement.

Undeclared Egg Allergen

Undeclared Coconut in the Contains statement.

Flow Beverages Inc., 33 Lakeview CT., Verona, VA, 24482 is initiating a recall of Flow Alkaline Spring Water - Organic lemon & ginger flavored water, 500 ml 12 units per case, Lots 2023AUG29 V5 and 2023AUG29 V5 because of four (4) customer complaints of alleged adverse reactions following the consumption of Flow organic lemon + ginger flavored water, 16.9 fl oz. (500 ml),

Contains statement declares Fish but does not specify the name of fish.