Consumer Product Recalls

Hazard: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

Hazard: Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.

Hazard: It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.

Hazard: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

Hazard: The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

Hazard: Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

Hazard: Undeclared Yellow #5

Hazard: Undeclared Yellow #5

Hazard: Undeclared Yellow #5

Hazard: Undeclared allergen (wheat).

Hazard: Potential contamination with Listeria monocytogenes.

Hazard: Potential contamination with Listeria monocytogenes.

Hazard: Potential contamination with Listeria monocytogenes.

Hazard: Potential contamination with Listeria monocytogenes.

Hazard: Potential contamination with Listeria monocytogenes.

Hazard: Potential contamination with Listeria monocytogenes.

Hazard: Potential contamination with Listeria monocytogenes.

Hazard: Potential contamination with Listeria monocytogenes.

Hazard: Potential contamination with Listeria monocytogenes.

Hazard: Product label contains conflicting statements about inclusion and being free of Soy ingredient.

Hazard: contains undeclared wheat

Hazard: Microbial contamination with Escherichia coli O7:K1 and E. Coli 1303.

Hazard: Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in the contain statement.

Hazard: Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in the contain statement.

Hazard: Product may be contaminated with Listeria monocytogenes.

Hazard: Potential yeast contamination.

Hazard: Product contains undeclared milk and shrimp

Hazard: Listeria monocytogenes. Recall was initiated after being notified by green onion supplier of a Listeria monocytogenes positive test result in the green onions which were used only in Ahi Tuna Wasabi Poke.

Hazard: undeclared allergen ingredient Milk.

Hazard: undeclared allergen ingredient Milk.