Nitinol Staple — Class II medical device recall Z-2265-2018
Terminated recall by TriMed Inc., reported 2018-06-27, distributed in CA, FL, IL, KS, MN, MO, MS, NC…. During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose
| Recall number | Z-2265-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TriMed Inc., Santa Clarita, CA, United States |
| Recall initiated | 2018-04-13 |
| Classified | 2018-06-20 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2021-01-22 |
| Distributed | CA, FL, IL, KS, MN, MO, MS, NC, NJ, NV, PA, TX, UT, WA |
| Countries outside the US | AU, SE |
| Quantity | 1,194 |
Product
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2265-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.