FDA Device recall Z-1008-2024
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx
- FDA Device
- Class II
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx by Brasseler Usa I, citing the device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1008-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-11 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Brasseler Usa I |
| Distribution | US |
Product
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Reason
The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
Identifiers
| code_info | Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1008-2024%22
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