SurgiCount 0694-001-010Recalls & reported problems
Stryker Corporation · SurgiCount? Tablet · Class 1
All models of SURGICOUNT (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327298284), received between Jul 11, 2024 and Jul 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2 reports).
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 Positive Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2025False Positive Result; False Positive Result
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FALSE POSITIVE RESULT. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587180 ↗MalfunctionJul 11, 2024False Positive Result; False Positive Result
PER THE ACCOUNT, THE TABLET DID NOT INDICATE A WOUND PACK WAS STILL PRESENT, WHICH COULD LEAD TO A SPONGE BEING RETAINED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19725934 ↗
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- 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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