Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Triton Canister System (finished part numbers FG 12009 Recalled by Stryker Instruments Div. of Stryker Corporation Due to Some Canister Scanning Labels used to calibrate the...

Date: January 22, 2020
Company: Stryker Instruments Div. of Stryker Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Instruments Div. of Stryker Corporation directly.

Affected Products

Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.

Quantity: 16,700 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Instruments Div. of Stryker Corporation

Stryker Instruments Div. of Stryker Corporation has 161 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report