OMNI K1 Broach Handle — Class II medical device recall Z-0837-2019
Terminated recall by OMNIlife science Inc., reported 2019-02-20, distributed in CA, GA, SC, UT. There is a potential for the inner pin of the handle to become loose and fall out.
| Recall number | Z-0837-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OMNIlife science Inc., Raynham, MA, United States |
| Recall initiated | 2018-11-29 |
| Classified | 2019-02-14 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2020-04-16 |
| Distributed | CA, GA, SC, UT |
| Quantity | 7 |
| Lot numbers | MM0118 |
Product
OMNI K1 Broach Handle, Product Code HS-10054
Reason for recall
There is a potential for the inner pin of the handle to become loose and fall out.
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-0837-2019. 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.