Brasseler 8S RA SHP RD — Class II medical device recall Z-1008-2024
Ongoing recall by Brasseler USA I Lp, reported 2024-02-14, distributed nationwide. The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch
| Recall number | Z-1008-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brasseler USA I Lp, Savannah, GA, United States |
| Recall initiated | 2024-01-11 |
| Classified | 2024-02-07 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 440 burs |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00887919188483 |
| Lot numbers | L01G6, L16P9 |
| Model numbers | 001156T0 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1008-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.