Brasseler Dental Bur (Brasseler) – Grip Detail Defect (2024)
Dental bur grip detail may not adequately latch in handpiece.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Brand
Brasseler USA I Lp
Lot Codes / Batch Numbers
Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.
Products Sold
Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.
Brasseler USA I Lp is recalling Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/pa due to The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
Recommended Action
Per FDA guidance
The recalling firm issued letters dated 1/8/2024 on 1/11/2024 via certified mail. The letter explains the reason for recall and required customer actions. The actions included that upon receipt of the letter, confirm the quantity of unused recalled product in their inventory and set it aside for return. Return information will be emailed to the consignee with a return label. The Customer Service emailed the letters to consignees on 1/12/2024 and sent product return instructions in the email. Phone calls will be made on 1/16/2024 if no response if received from the consignee via email. The recalling firm will be recording the amount of product to be returned on the phone log which will be completed for every consignee contacted. During the call, the consignees will also be given the product return instructions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026