Omnia recalls specific dental instruments due to inadequate sterilization processes at a contracted facility since 2016, posing infection risks. Affected models and lots listed.
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.
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.
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.
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.
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.
Identify the model and lot numbers on the instrument to confirm if it is affected by this recall.
Omnia received a notification that their contracted sterilizing facility did not follow proper sterilization processes since 2016, which could lead to infections.
Affected models include 32.Z2000.00 through 32.Z2038.00 and 72.T1950.00 through 72.T1953.00. Lot numbers range from 118 to 4820A as listed in the recall.
The recall does not require immediate stop use; dentists should check model and lot numbers to confirm if affected and follow the recall instructions.
We’ve drafted a message you can send Omnia to request your refund or repair — edit it as you like.
Subject: Recall Z-1518-2021 — Omnia Omnia Hello, I own a Omnia that is covered by recall Z-1518-2021 from Omnia. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
