# FDA recall Z-2961-2026

> **Boston Scientific Corporation** · Class II · device recall initiated 2026-07-14.

## Product

OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.

## Reason for recall

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

## Distribution

Worldwide distribution - US Nationwide and the countries of Austria, Azerbaijan, Belgium, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malta, Netherlands, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, United Kingdom.

## Key facts

- **Recall number:** Z-2961-2026
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-14
- **Report date:** 2026-08-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2961-2026

## Citation

> AI Analytics. FDA recall Z-2961-2026. Retrieved 2026-09-21 from https://api.ai-analytics.org/recall/Z-2961-2026. Source: US FDA. Licensed CC0.

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