Home › STERIS CORPORATION › ORLocate
ORLocate
STERIS CORPORATION · Model ORLocate Sponge Solution · UDI-DI 00724995243685
1
510(k) clearances
580
Adverse events
4
Recalls
48
Facilities
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | United Orthopedic Corp. | Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. |
| 2022-06-15 | Stryker Instruments Div. of Stryker Corporation | When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. |
| 2016-03-21 | Stryker Instruments Div. of Stryker Corporation | The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). |
| 2013-06-16 | Stryker Instruments Div. of Stryker Corporation | Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.