All Recalls

FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing.

The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.

BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in surgery. If not retrieved, it may cause an inflammatory response that may require revision surgery.

Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.

The heaters can re-start unexpectedly while in standby mode if the room temperature falls below the thermostat set point, posing fire and carbon monoxide poisoning hazards.

The sprayer's rechargeable lithium-ion battery pack can overheat and melt, posing a risk of the product catching fire and/or exploding.

Cookie dough ingredient intended for use in ice cream may be contaminated with Listeria monocytogenes.

Undeclared wheat.

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,

Product is potentially contaminated with mold.

Potential elevated levels of histamine.

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,