Class II — Brasseler USA, Medical L.L.C.
| Recalling firm | Brasseler U.S.A. Medical, LLC |
|---|---|
| Registered facility | Brasseler U.S.A. Medical, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | One lot of product was distributed in unsealed packaging |
| Product | Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S |
| Quantity | 231 units |
| Distribution | US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID. |
| Initiated | 2022-01-28 |
| Classified | 2022-03-01 |
| Terminated | 2023-02-03 |
| Recall number | Z-0707-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Brasseler USA, Medical L.L.C. (Z-0707-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89555/
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