Medtronic (NYSE:MDT) said in late May it initiated a voluntary field action to recall its Midas Rex Sagittal Saws over issues with potential leakage of fluid into the motor through the units Rocker Housing Seal.

Midas Rex Sagittal Saws are designed to be used with its Integrated Power Console system for the cutting, removal and sawing of soft and hard tissue and bone in neurosurgical, orthopedic, arthroscopic, spinal, sternotomy and general surgical procedures.

The Fridley, Minn.-based company said it has received no reports of fluid leakage in the field.  The issue was identified during engineering testing of the Rocker Housing Seal, which is intended to prevent ingress of fluid into the saws during use and decontamination.

Medtronic said it tested the potential failure and found that the indicated gravity displacement sterilization cycle recommended for the device “may not be adequate to ensure sterility of internal motor components if fluid ingress occurs beyond the Rocker Housing Seal,” according to an urgent field safety notice from the company.

A serious risk could emerge if fluid from the motor leaks from the housing and contacts another patient’s surgical site, Medtronic said. The risk is lowered if a vacuum sterilization method is used, the company added.

Medtronic requested that customers quarantine any affected devices and return them, with “replacements based on the limited availability at our disposal,” according to the safety notice.

Earlier last month, the FDA slapped a Class I label on Medtronic’s voluntary recall of battery packs used with its Covidien Oridion labeled Capnostream 20 and 20p patient monitors.

The devices are being recalled due to a defect causing an increased risk of thermal damage in the packs.