Triton 0894000001Recalls & reported problems
Stryker Corporation · AI Software · Class 2
All models of TRITON (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327622768), received between Aug 28, 2024 and Jan 23, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “High Readings” (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
- High Readings1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Low Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Low Readings
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 23399818 ↗MalfunctionAug 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091227 ↗
Other Image processing device for estimation of external blood loss devices
- TRITON FG-12010Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss2 recalls0 reports
- Triton Canister System FG-12009Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss2 recalls0 reports
- TRITON GAUS-2Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss1 recall5 reports
- TRITON GAUS-3Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss1 recall0 reports
- TRITON FG-12022Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss1 report
- N/A 0894000004Stryker Corporation · Image processing device for estimation of external blood loss1 report
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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