Omnia Soft Tissue Punch Recall: Inadequate Sterilization Risk
Omnia recalls specific dental instruments due to inadequate sterilization processes at a contracted facility since 2016, posing infection risks. Affected models and lots listed.
Lower-risk recall
Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016.
Contact the company
What happened, in plain English
Omnia is recalling dental instruments called Soft Tissue Punches that may not have been properly sterilized since 2016. This could lead to infections if used on patients. Read more at govinfonow.com/recall/62887-omnia-soft-tissue-punch-recall-inadequate-sterilization-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62887-omnia-soft-tissue-punch-recall-inadequate-sterilization-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1518-2021
Cite this page
“Omnia Soft Tissue Punch Recall: Inadequate Sterilization Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62887-omnia-soft-tissue-punch-recall-inadequate-sterilization-risk. Based on FDA recall #Z-1518-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1518-2021%22&limit=1).
Why it’s dangerous
The instruments were sterilized at a contracted facility that did not follow proper procedures since 2016. This could lead to infections if the instruments are used on patients without being properly sterilized.
Who’s affected
Dentists and dental clinics using Omnia Soft Tissue Punches with model numbers listed in the recall. Patients are at risk if the instrument is used without proper sterilization.
How to tell if you have this one
Check for model numbers: 32.Z2000.00 through 32.Z2038.00, 72.T1950.00 through 72.T1953.00. Lot numbers include 118, 317, 319, and others listed in the recall.
- Brand
Omnia- Category
Medical device
What to do — step by step
Check Model and Lot Numbers
Identify the model and lot numbers on the instrument to confirm if it is affected by this recall.
Where it went and when
Where it was distributed
Distributed in 8 states, and outside the U.S.
FDA distribution: “Domestic: AK, IL, PA, OK, TX, UT, NY, CA. Foreign: Australia, Austria, Belgium, Bulgaria, Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Lebanon, Netherlands, New Zealand, Poland, Russia, Slovenia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alaska, California, Illinois, New York, Oklahoma, Pennsylvania, Texas, Utah.
Recall timeline
FDA terminated this recall 2.6 years 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-1518-2021 (March 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1518-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.