TRITONRecalls & reported problems across all models
Stryker Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one TRITON model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 4
We found 5 models of TRITON by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between May 16, 2024 and Jan 23, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “High Readings” (5 reports).
4 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
TRITON recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 25, 2023Open, Classified
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Z-1186-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 25, 2023Open, Classified
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Z-1184-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 22, 2020Terminated
Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.
Z-1402-2022 · Root cause: Process control · Recall details · FDA record ↗
- Dec 4, 2018Terminated
Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
Z-1394-2022 · Root cause: Use error · Recall details · FDA record ↗
Most reported TRITON problems
Device problems
- High Readings5
- Low Readings3
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
TRITON models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRITON FG-12010Image Processing Device For Estimation Of External Blood Loss2 recalls0 reports
- TRITON GAUS-2Image Processing Device For Estimation Of External Blood Loss1 recall5 reports
- TRITON GAUS-3Image Processing Device For Estimation Of External Blood Loss1 recall0 reports
- Triton 0894000001Image processing device for estimation of external blood loss3 reports
- TRITON FG-12022Image Processing Device For Estimation Of External Blood Loss1 report
Recent TRITON adverse event reports
The 9 most recent reports across all models, 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 ↗MalfunctionSep 25, 2024High Readings; High Readings
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20305511 ↗MalfunctionSep 25, 2024High Readings; High Readings
DURING A PROCEDURE WITH HEMORRHAGING, THE QUANTITATIVE BLOOD LOSS WAS SIGNIFICANTLY LOWER THAN THE ESTIMATED BLOOD LOSS ON THE DEVICE. 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 20305405 ↗MalfunctionSep 25, 2024High Readings; High Readings
DURING A PROCEDURE WITH HEMORRHAGING, THE QUANTITATIVE BLOOD LOSS WAS SIGNIFICANTLY LOWER THAN THE ESTIMATED BLOOD LOSS ON THE DEVICE. 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 20305214 ↗MalfunctionSep 5, 2024High Readings; High Readings
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20146253 ↗MalfunctionAug 29, 2024Low Readings; Low Readings
PER THE ACCOUNT, THE TRITON CANISTER SOFTWARE GAVE A LOW ESTIMATED BLOOD LOSS READING DURING A PROCEDURE. 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 20095515 ↗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 ↗MalfunctionMay 16, 2024Low Readings; Low Readings
PER THE ACCOUNT, DURING A CASE THE DEVICE SHOWED AN ESTIMATED BLOOD LOSS LOWER THAN EXPECTED. THE DEVICE REFLECTED BLOOD LOSS READINGS OF 230ML, 411ML, AND 200ML. THE SURGEON FELT THE BLOOD LOSS SHOULD BE AROUND 800ML. 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 19338193 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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