Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2022 - (Recall #: Z-1402-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 22, 2020

Date Posted: July 27, 2022

Recall Number: Z-1402-2022

Event ID: 90464

Reason for Recall:

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.

Status: Terminated

Product Quantity: 16,700 units

Code Information:

UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated