CLASS II Device recall · Reported 5 May 2021 · FDA Enforcement Report

Soft Tissue Punch is a dental instrument designed to remove recalled

Omnia SRL is recalling Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a, distributed in 8 states. The recall was initiated on 30 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot:118, 317, 319, 516, 616, 617, 618, 620, 716, 719, 720, 817, 818, 916, 920, 1016, 1018, 1216, 1217, 1316, 1317, 1318, 1319, 1418, 1516, 1618, 1718, 1720, 1816, 1817, 1918, 1919, 2018, 2117, 2118, 2119, 2216, 2316, 2319, 2416, 2417, 2619, 2713, 2717, 2718, 2719, 2816,2818, 2819, 2916, 3218, 3219, 3416, 3517,3716, 3719, 3816, 3818, 3916, 3917, 3918, 3919, 4118, 4217, 4220, 4318, 4320, 4416, 4417, 4419, 4617, 4715, 4716, 4816, 4819, 4820, 4915, 4920, 5118, 5319, 0317, 190B, 1920A, 1920B, 2518A, 2518B, 4820A

Quantity recalled276,901 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1518-2021
FDA event ID: 87680
Recalling firm: Omnia SRL, Fidenza, N/A
Classification: Class II
Status: Terminated
Recall initiated: 30 Mar 2021
FDA classified: 29 Apr 2021
Reported: 5 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

30 Mar 2021	Recall initiated by company
29 Apr 2021	Classified by FDA	+30 days
5 May 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Model: 32.Z2000.00, 32.Z2002.00, 32.Z2004.00, 32.Z2006.00, 32.Z2007.00, 32.Z2008.00, 32.Z2009.00, 32.Z2020.00, 32.Z2022.00, 32.Z2024.00, 32.Z2026.00, 32.Z2027.00, 32.Z2028.00, 32.Z2030.00, 32.Z2032.00, 32.Z2034.00, 32.Z2036.00, 32.Z2038.00, 32.Z2040.00, 72.T1950.00, 72.T1951.00, 72.T1952.00, 72.T1953.00

Where it was distributed

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, Spain, Sweden, Switzerland, United Kingdom, Uzbekistan, Canada, Malta,

Alaska California Illinois New York Oklahoma Pennsylvania Texas Utah

Stores named: Walmart

Questions about this recall

Is Soft Tissue Punch is a dental instrument designed to remove with precision a circular recalled?

Yes. Omnia SRL recalled Soft Tissue Punch is a dental instrument designed to remove with precision a circular on 30 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1518-2021.

Why was it recalled?

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.

Which lots are affected?

Lot:118, 317, 319, 516, 616, 617, 618, 620, 716, 719, 720, 817, 818, 916, 920, 1016, 1018, 1216, 1217, 1316, 1317, 1318, 1319, 1418, 1516, 1618, 1718, 1720, 1816, 1817, 1918, 1919, 2018, 2117, 2118, 2119, 2216, 2316, 2319, 2416, 2417, 2619, 2713, 2717, 2718, 2719, 2816,2818, 2819, 2916, 3218, 3219, 3416, 3517,3716, 3719, 3816, 3818, 3916, 3917, 3918, 3919, 4118, 4217, 4220, 4318, 4320, 4416, 4417, 4419, 4617, 4715, 4716, 4816, 4819, 4820, 4915, 4920, 5118, 5319, 0317, 190B, 1920A, 1920B, 2518A, 2518B, 4820A

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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