Agency classClass IIOur severity:High FDA (Devices)·Z-1186-2023·Announced 2023-03-08

Triton Canister Software Labeling May Cause Inaccurate Blood Loss Estimates

Stryker is recalling Triton Canister Software due to labeling issues that may cause inaccurate blood loss estimates. This could delay recognition of or prolong postpartum hemorrhage, potentially requiring more aggressive treatment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II medical device recall with no reported illnesses or injuries. Qualifies as risk-of-harm product where injury has not yet been reported per Score 3 criterion.

Plain-English summary

Stryker Corporation is recalling the Triton Canister Software (Catalog Number GAUS-2; UDI-DI: 00859506006029; Software Version 2.8.4). This device serves as an adjunct in estimating blood loss. Approximately 88 units have been distributed nationwide throughout the United States.

The Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates. These inaccurate readings could lead to confusion and potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or may require more aggressive treatment for PPH.

The recalled product

Product: Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Manufacturer: Stryker Corporation
Category: Medical Device — Surgery / Intraoperative Monitoring
Hazard: mis-labeling
inaccurate-readings
Affected units: 88

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI-DI: 00859506006029 Software Version: 2.8.4

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Stryker Corporation

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Same hazard · mis labeling