Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF… recallZ-1008-2024 · Brasseler USA I Lp · initiated Jan 11, 2024
Class II Open, Classified All recalls posted in February 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Brasseler USA I Lp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1008-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jan 11, 2024
- Posted by the FDA
- Feb 7, 2024
- Recalling firm
- Brasseler USA I Lp
- Quantity
- 440 burs
- Product code
- EJL
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, IL, NY, OH, OR, PA, TN, TX, and WA. The country of Canada.
Product description
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Code information (models, lots, serial numbers)
Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Brasseler USA 001156T0Peter Brasseler Holdings, LLC · BUR, DENTAL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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