# FDA recall Z-2115-2019

> **Burlington Medical, LLC** · Class II · device recall initiated 2019-06-07.

## Product

Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M

## Reason for recall

The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.

## Distribution

US Nationwide distribution.    The products were distributed to the following foreign countries:  Korea, Thailand.

## Key facts

- **Recall number:** Z-2115-2019
- **Recalling firm:** Burlington Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-07
- **Report date:** 2019-08-07
- **Termination date:** 2023-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newport News, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2115-2019

## Citation

> AI Analytics. FDA recall Z-2115-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2115-2019. Source: US FDA. Licensed CC0.

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