FDA Device recall Z-0837-2019
OMNI K1 Broach Handle, Product Code HS-10054
- FDA Device
- Class II
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class II recall of OMNI K1 Broach Handle, Product Code HS-10054 by Omnilife Science, citing there is a potential for the inner pin of the handle to become loose and fall out.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0837-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-29 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Omnilife Science |
| Distribution | CA, GA, SC, UT |
Product
OMNI K1 Broach Handle, Product Code HS-10054
Reason
There is a potential for the inner pin of the handle to become loose and fall out.
Identifiers
| code_info | Lot Number MM0118 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0837-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.