# FDA recall Z-1185-2023

> **Stryker Corporation** · Class II · device recall initiated 2023-01-25.

## Product

Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L  Catalog Number: FG 12022.  Intended adjunct in the estimation of blood loss.

## Reason for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1185-2023
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-25
- **Report date:** 2023-03-08

- **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-1185-2023

## Citation

> AI Analytics. FDA recall Z-1185-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1185-2023. Source: US FDA. Licensed CC0.

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