CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023 recalled
Brasseler USA I is recalling Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, distributed nationwide in the US. The recall was initiated on 11 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1008-2024
- FDA event ID
- 93809
- Recalling firm
- Brasseler USA I, Savannah, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jan 2024
- FDA classified
- 7 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Dental Devices
Timeline
| 11 Jan 2024 | Recall initiated by company | |
| 7 Feb 2024 | Classified by FDA | +27 days |
| 14 Feb 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Where it was distributed
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.
Nationwide AlabamaCaliforniaColoradoDistrict of ColumbiaIllinoisNew YorkOhioOregonPennsylvaniaTennesseeTexasWashington
Questions about this recall
Why was it recalled?
The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
Which lots are affected?
Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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