# FDA recall Z-0835-2018

> **Stryker Corporation** · Class II · device recall initiated 2017-11-17.

## Product

StrykeFlow 2 System, labeled sterile.  Includes the following:    a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500);    b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505);    c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520)    STRYKER LAPAROSCOPIC SUCTION IRRIGATOR

## Reason for recall

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

## Distribution

Distributed domestically to .      Distributed internationally to Australia and Mexico.

## Key facts

- **Recall number:** Z-0835-2018
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-17
- **Report date:** 2018-03-14
- **Termination date:** 2024-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0835-2018

## Citation

> AI Analytics. FDA recall Z-0835-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0835-2018. Source: US FDA. Licensed CC0.

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