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ORLocate ORLocate Sponge SolutionRecalls & reported problems

Steris Corporation · ORLocate Sponge Solution is an innovative counting and locating technology that enhances patient safety and reduces time spent counting and searching for sponges in the operating room. · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995220624), received between Apr 28, 2023 and Apr 28, 2023 — classified as 1 malfunction.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    STERIS WAS CONTACTED BY AN ATTORNEY REPRESENTING THE USER FACILITY ON 3/31/2023 REGARDING LITIGATION ALLEGING A SPONGE WAS LEFT IN A PATIENT'S PELVIC CAVITY DURING A PROCEDURE THAT OCCURRED ON (B)(6) 2020. IT WAS REPORTED THAT THE PROCEDURE SUBJECT OF THE EVENT INCLUDED USE OF THE OR LOCATE SPONGE SOLUTION.

    Patient problems: Foreign Body In Patient

    MAUDE report 16834167 ↗

Other Counter, sponge, surgical devices

All Counter, sponge, surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.