TRITON FG-12022Recalls & reported problems

Stryker Corporation · TRITON 3L CANISTER INSERT KIT · Class 2

All models of TRITON (5)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859506006258), received between May 16, 2024 and May 16, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Low Readings1

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.

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 ↗

Device details

UDI-DI	`00859506006258`
Brand	TRITON
Model	FG-12022
Company	Stryker Corporation
Product code	PBZ · Image Processing Device For Estimation Of External Blood Loss
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 8, 2023

Device type (GMDN): Blood loss estimation canister insert/label

A device in the form of a shaped plastic insert or an adhesive sticker intended to be placed in and/or on a surgical suction system canister to facilitate estimation of the quantity of external blood loss during a surgical procedure. It provides a uniform background and standardization of ambient lighting conditions to improve the quality of images taken by a device that runs blood loss estimation application software. The label may also be used as a device identifier. This is a single-use device.

Other Image Processing Device For Estimation Of External Blood Loss devices

TRITON FG-12010
Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss
2 recalls0 reports
Triton Canister System FG-12009
Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss
2 recalls0 reports
TRITON GAUS-2
Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss
1 recall5 reports
TRITON GAUS-3
Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss
1 recall0 reports
Triton 0894000001
Stryker Corporation · Image processing device for estimation of external blood loss
3 reports
N/A 0894000004
Stryker Corporation · Image processing device for estimation of external blood loss
1 report

All Image Processing Device For Estimation Of External Blood Loss devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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