Brasseler USA I Lp: Medical Device Recall in 2024 - (Recall #: Z-1008-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

Product Classification:

Class II

Date Initiated: January 11, 2024

Date Posted: February 14, 2024

Recall Number: Z-1008-2024

Event ID: 93809

Reason for Recall:

The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.

Status: Ongoing

Product Quantity: 440 burs

Code Information:

Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated