# FDA recall Z-2452-2020

> **LivaNova USA Inc.** · Class II · device recall initiated 2020-04-24.

## Product

Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283

## Reason for recall

The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.

## Distribution

US - AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV    OUS- Spain (Hospital de Barsuto, Bilbao, Spain)

## Key facts

- **Recall number:** Z-2452-2020
- **Recalling firm:** LivaNova USA Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-24
- **Report date:** 2020-07-08
- **Termination date:** 2022-02-17

- **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-2452-2020

## Citation

> AI Analytics. FDA recall Z-2452-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2452-2020. Source: US FDA. Licensed CC0.

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