Brasseler dental burs recalled due to defective latching mechanism
Brasseler USA recalls 440 dental burs due to right angle latch specification failure that prevents proper latching in dental handpieces.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a documented specification failure that creates a risk-of-harm situation. While no injuries have been reported, the inability to latch properly could lead to device malfunction during dental procedures.
Plain-English summary
Brasseler USA I Lp is recalling 440 carbide dental burs (model 8S RA SHP RD, Super-Sharp Round, H1S.21.023, ref 001156T0) in 10-unit packages. Lot numbers affected are L01G6 and L16P9.
The right angle latch on these burs is out of specification, causing the bur to not adequately latch in the dental handpiece. This functional defect could prevent proper operation during dental procedures.
The affected burs were distributed nationwide in Alabama, California, Colorado, Washington DC, Illinois, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Washington, and in Canada.
The recalled product
- Product
- Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
- Manufacturer
- Brasseler USA I Lp
- Hazard
- improper-latching
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot numbers L01G6 and L16P9
- UDI-DI 00887919188483
- RX.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27