SurgiCount 0894000005Recalls & reported problems
Stryker Corporation · + QBL Software · Class 1
All models of SURGICOUNT (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327622799), received between Dec 12, 2024 and Oct 28, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “High Readings” (3 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
- High Readings3
- Low Readings2
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2025Low Readings; Low Readings
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: LOW READINGS. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399870 ↗MalfunctionOct 28, 2025High Readings; High Readings
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: HIGH READINGS. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399794 ↗MalfunctionJul 29, 2025Low Readings; Low Readings
THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: LOW READINGS. - 4 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22648155 ↗MalfunctionJul 29, 2025High Readings; High Readings
THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: HIGH READINGS. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22648141 ↗MalfunctionJul 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: INCORRECT, INADEQUATE OR IMPRECISE RESULT OR READINGS. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22646714 ↗MalfunctionDec 12, 2024High Readings; High Readings
PER THE USER FACILITY, AFTER A PROCEDURE THE WEIGHT SHOWN FOR THE LAP SPONGES WAS HIGHER THAN EXPECTED. THE DEVICE DISPLAYED AN ERROR MESSAGE. THE USER FACILITY MANUALLY WEIGHED THE SPONGES AND DETERMINED THE ESTIMATED BLOOD LOSS WAS INCORRECT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20916472 ↗
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
- Situate 01-0043RCovidien LP · Counter, sponge, surgical5 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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