# FDA recall Z-2642-2020

> **LivaNova USA Inc.** · Class III · device recall initiated 2019-11-18.

## Product

LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case

## Reason for recall

Some packages of sterile disposable connectors contained a 3/8x1/4 reducer  instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.

## Distribution

Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.

## Key facts

- **Recall number:** Z-2642-2020
- **Recalling firm:** LivaNova USA Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-18
- **Report date:** 2020-07-29
- **Termination date:** 2021-08-19

- **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-2642-2020

## Citation

> AI Analytics. FDA recall Z-2642-2020. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2642-2020. Source: US FDA. Licensed CC0.

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