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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Brasseler USA I Lp: Super-Sharp Round Carbide Dental Burs Recalled Due to Latching Failure

Agency Publication Date: February 7, 2024
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Summary

Brasseler USA has recalled 440 units of its 8S RA Super-Sharp Round carbide dental burs because the grip detail on the right-angle latch was manufactured out of specification. This defect prevents the bur from properly latching into the dental handpiece during use. Without a secure connection, the bur could become loose or detached while in operation, potentially causing injury or disrupting medical procedures. These burs were distributed nationwide and in Canada between January and February 2024.

Risk

The dental bur may not securely latch into the handpiece, which can cause the rotating tool to slip or fall out during a dental procedure, potentially injuring the patient or the healthcare provider.

What You Should Do

  1. Check your inventory for Brasseler 8S RA SHP RD (Super-Sharp Round) carbide dental burs (REF 001156T0).
  2. Specifically identify if you have packages from Lot numbers L01G6 or L16P9 with UDI-DI 00887919188483.
  3. Stop using any dental burs identified as part of the affected lots immediately to prevent injury during procedures.
  4. Contact your healthcare provider or Brasseler USA directly at 1-800-841-4522 or via their website at brasselerusa.com for instructions on returning the product and receiving a replacement or refund.
  5. For further questions or to report an issue, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification via letter

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023 (10 burs/package)
Model / REF:
H1S.21.023
REF 001156T0
UDI-DI 00887919188483
Lot Numbers:
L01G6
L16P9

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93809
Status: Active
Manufacturer: Brasseler USA I Lp
Sold By: Direct distribution; Dental supply distributors
Manufactured In: United States
Units Affected: 440 burs
Distributed To: Alabama, California, Colorado, District of Columbia, Illinois, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.