# FDA recall Z-1901-2018

> **LivaNova USA** · Class II · device recall initiated 2018-04-20.

## Product

Sorin Stockert Heater-Cooler System 3T,     a) Item #: 16-02-81, 240 v/60 Hz;    b) Item #: 16-02-82, 208 v/60 Hz;    c) Item #: 16-02-85, 120 v/60 Hz

## Reason for recall

Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.

## Distribution

MN, TX, WA, OR, IL, OH, SC, AK, PA, CA, WI, GA, NJ, FL, AZ, KY, MS, MO, LA, AR, MA, MI, MT, CO, TN, NE, NC, VA, NV, HI, PR, WY, AL, OK, IN, CT, ME, IA, SC, KS, NM, SD, DC, MD, ND,

## Key facts

- **Recall number:** Z-1901-2018
- **Recalling firm:** LivaNova USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-20
- **Report date:** 2018-05-30
- **Termination date:** 2025-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Arvada, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1901-2018

## Citation

> AI Analytics. FDA recall Z-1901-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1901-2018. Source: US FDA. Licensed CC0.

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