Class II — TriMed Inc.
| Recalling firm | TRIMED, INC. |
|---|---|
| Registered facility | TRIMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy. |
| Product | Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO |
| Quantity | 1525 devices |
| Distribution | US, China, Latin America |
| Initiated | 2018-01-11 |
| Classified | 2018-04-12 |
| Terminated | 2024-01-18 |
| Recall number | Z-1373-2018 |
| 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 — TriMed Inc. (Z-1373-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79224/
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