# FDA recall Z-0126-2024

> **SynCardia Systems LLC** · Class II · device recall initiated 2023-08-01.

## Product

SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

## Reason for recall

Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.

## Distribution

US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA,  OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany,  France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia

## Key facts

- **Recall number:** Z-0126-2024
- **Recalling firm:** SynCardia Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-08-01
- **Report date:** 2023-11-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tucson, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0126-2024

## Citation

> AI Analytics. FDA recall Z-0126-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0126-2024. Source: US FDA. Licensed CC0.

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