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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 440
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
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