Medical Devices Recalls

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Potential for failed stability antimicrobial effectiveness testing.

The products do not have sufficient data to support the labeled shelf life of 10 years.

Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results.

Lack of an adequate sterilization validation.

Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.

Potential for failed stability antimicrobial effectiveness testing.

There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.

Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.

The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.

The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.

Potential for a transducer mis-alignment in certain transvaginal probes.

If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.

If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered.

If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.

Potential for failed stability antimicrobial effectiveness testing.