All Recalls

The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.

The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Potential for demographic information and test result to be mismatch.

Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.

Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.

Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.

A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.

Risk of incorrect results from samples prepared with Panthera-Puncher 9

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.

Product is not approved or authorized for distribution in the US.