SURGICOUNT 0694002010Recalls & reported problems
Stryker Corporation · + SPONGE COUNTING BAG · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 37613327519502), received between Jul 1, 2025 and Jul 1, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
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.
InjuryJul 1, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
PER THE USER FACILITY, THE CIRCULATING NURSE CLOSED THE CASE BEFORE PERFORMING HER FINAL SPONGE COUNT. SINCE IT WAS A HIP PROCEDURE, X RAY WAS CALLED INTO THE ROOM TO SCAN THE PATIENT WHEN THE SPONGE WAS FOUND. AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE THE SPONGE. THE ADDITIONAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22372936 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page