# FDA recall Z-0998-2023

> **Bolton Medical Inc.** · Class II · device recall initiated 2022-12-20.

## Product

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX

## Reason for recall

The product may be shorter than packaging indicates

## Distribution

Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.

## Key facts

- **Recall number:** Z-0998-2023
- **Recalling firm:** Bolton Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-20
- **Report date:** 2023-01-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunrise, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0998-2023

## Citation

> AI Analytics. FDA recall Z-0998-2023. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-0998-2023. Source: US FDA. Licensed CC0.

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