# FDA recall Z-1640-2025

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2025-03-14.

## Product

Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device,  SterileEO, RxOnly

## Reason for recall

Update to IFU to provide additional information related to  risk with device over-rotation and multiple deployment of fasteners.

## Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, 	DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, 	NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, United Arab Emirates.

## Key facts

- **Recall number:** Z-1640-2025
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-14
- **Report date:** 2025-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1640-2025

## Citation

> AI Analytics. FDA recall Z-1640-2025. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1640-2025. Source: US FDA. Licensed CC0.

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