Brasseler USA I Lp
Brasseler USA I Lp has 3 FDA enforcement events on this register (3 product records) between 2019 and 2024: 3 device; the busiest year was 2019 with 2.
0% of its events are Class I; the most common class is Class II (3). 1 event is listed as ongoing; the recalling firm's address is in GA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 11 Jan 2024 | Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx. | Device | Class II | 1 | Ongoing |
| 11 Dec 2019 | Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures. | Device | Class II | 1 | Terminated |
| 18 Oct 2019 | BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries. | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Brasseler USA I Lp had?
3 enforcement events (3 product records) on this register, 2019–2024: 3 device.
Are any Brasseler USA I Lp recalls ongoing?
1 event is listed as ongoing in the current openFDA export.
What class are Brasseler USA I Lp recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.