SurgiCount 0894000003Recalls & reported problems
Stryker Corporation · + Sponge Counting Software · Class 1
All models of SURGICOUNT (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 07613327622751), received between Feb 6, 2026 and Feb 6, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026False Negative Result
THE CUSTOMER REPORTED THAT DURING A CASE, SPONGES WERE SCANNED IN AND THEN OUT, AN ERROR OCCURRED AND THE CASE REPORTED NONE OF THE SPONGES WERE SCANNED OUT. AN X-RAY WAS TAKEN TO CONFIRM NO SPONGES WERE RETAINED. NO ADVERSE CONSEQUENCES OR ADDITIONAL MEDICAL INTERVENTION WAS TAKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279483 ↗
Other Counter, sponge, surgical devices
- SURGICOUNT 0694002090Stryker Corporation · Counter, sponge, surgical2 recalls0 reports
- Situate 01-0031Covidien LP · Counter, sponge, surgical97 reports
- Situate 01-0043Covidien LP · Counter, sponge, surgical94 reports
- Situate 01-0034Covidien LP · Counter, sponge, surgical67 reports
- Situate 01-0035Covidien LP · Counter, sponge, surgical18 reports
- Situate 01-0046Covidien LP · Counter, sponge, surgical10 reports
- N/A 0794001010Stryker Corporation · Counter, sponge, surgical7 reports
- SurgiCount 0894000005Stryker Corporation · Counter, sponge, surgical6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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