OMNI K1 Broach Handle Recall: Loose Inner Pin Risk
OMNIlife recalls OMNI K1 Broach Handle (Product Code HS-10054) due to potential inner pin loosening and falling out. Affected units sold with Lot Number MM0118.
Use caution until it’s fixed
There is a potential for the inner pin of the handle to become loose and fall out.
Contact the company
What happened, in plain English
OMNIl:ife recalls its OMNI K1 Broach Handle (Product Code HS-10054) because the inner pin might become loose and fall out. This could cause the handle to detach during use, potentially leading to injury. Read more at govinfonow.com/recall/69415-omni-k1-broach-handle-recall-loose-inner-pin-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69415-omni-k1-broach-handle-recall-loose-inner-pin-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0837-2019
Cite this page
“OMNI K1 Broach Handle Recall: Loose Inner Pin Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69415-omni-k1-broach-handle-recall-loose-inner-pin-risk. Based on FDA recall #Z-0837-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0837-2019%22&limit=1).
Why it’s dangerous
The inner pin in the handle can become loose and fall out during normal use. If the pin detaches, the handle may become unstable, increasing the risk of injury from slipping or dropping.
Who’s affected
Users of the OMNI K1 Broach Handle with Product Code HS-10054 and Lot Number MM0118 are affected. People using the handle for precision tasks are at higher risk due to potential detachment.
How to tell if you have this one
Check for the product code HS-10054 and lot number MM0118 on the handle. The recall applies to OMNI K1 Broach Handles sold by OMNIlife science Inc.
- Brand
OMNIlife- Category
Medical device
What to do — step by step
Check Handle Stability
Inspect the handle for any signs of looseness or movement in the inner pin.
Where it went and when
Where it was distributed
Distributed in 4 states.
FDA distribution: “The products were distributed to the following US states: CA, GA, SC, and UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Georgia, South Carolina, Utah.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0837-2019 (November 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0837-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.