Class II — TriMed Inc.
| Recalling firm | TRIMED, INC. |
|---|---|
| Registered facility | TRIMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized. |
| Product | Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22 |
| Quantity | 323 |
| Distribution | U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden |
| Initiated | 2018-04-13 |
| Classified | 2018-06-20 |
| Terminated | 2021-01-22 |
| Recall number | Z-2263-2018 |
| 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-2263-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80099/
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