# FDA recall Z-1402-2022

> **Stryker Instruments Div. of Stryker Corporation** · Class II · device recall initiated 2020-01-22.

## Product

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.

## 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.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-1402-2022
- **Recalling firm:** Stryker Instruments Div. of Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-22
- **Report date:** 2022-07-27
- **Termination date:** 2024-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1402-2022

## Citation

> AI Analytics. FDA recall Z-1402-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1402-2022. Source: US FDA. Licensed CC0.

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