Z-1008-2024Class II

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

Name: Z-1008-2024 Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx
Creator: Brasseler USA I Lp
Published: 2024-01-11
License: https://open.fda.gov/license/

Brasseler USA I, L.P. / initiated 2024-01-11 / Open, Classified

FDA source

Brasseler USA I Lp began a recall of Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx on 2024-01-11. FDA classified it as Class II and gives the reason as "The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1008-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-11
Posted: 2024-02-07
Recalling firm: Brasseler USA I, L.P.
Product: Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Product code: EJL Bur, Dental
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 440 burs
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 codes and lots: Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1008-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1008-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-07

Product code EJL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)