# FDA recall Z-1008-2024

> **Brasseler USA I Lp** · Class II · device recall initiated 2024-01-11.

## Product

Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

## Reason for recall

The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.

## Distribution

Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, IL, NY, OH, OR, PA, TN, TX, and WA. The country of Canada.

## Key facts

- **Recall number:** Z-1008-2024
- **Recalling firm:** Brasseler USA I Lp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-11
- **Report date:** 2024-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Savannah, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2024

## Citation

> AI Analytics. FDA recall Z-1008-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1008-2024. Source: US FDA. Licensed CC0.

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