# FDA recall Z-2767-2020

> **Boss Instruments, Ltd.** · Class II · device recall initiated 2020-06-26.

## Product

BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.

## Reason for recall

The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of CA, TN, TX and the countries of England, Japan, New Zealand, South Africa, South Korea, Taiwan.

## Key facts

- **Recall number:** Z-2767-2020
- **Recalling firm:** Boss Instruments, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-26
- **Report date:** 2020-08-12
- **Termination date:** 2021-07-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Zion Crossroads, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2767-2020

## Citation

> AI Analytics. FDA recall Z-2767-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2767-2020. Source: US FDA. Licensed CC0.

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