Omnia Soft Tissue Punch is a dental instrument designed to remove… — Class II medical device recall Z-1518-2021
Terminated recall by Omnia SRL, reported 2021-05-05, distributed in AK, CA, IL, NY, OK, PA, TX, UT. Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization pr
| Recall number | Z-1518-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Omnia SRL, Fidenza, N/A, Italy |
| Recall initiated | 2021-03-30 |
| Classified | 2021-04-29 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2023-11-08 |
| Distributed | AK, CA, IL, NY, OK, PA, TX, UT |
| Countries outside the US | AT, AU, BE, BG, CA, CH, DE, DK, DO, EE, ES, FR, GB, GR, HU, IE, IT, LB, MT, NL, NZ, PL, RU, SE, SI |
| Quantity | 276,901 units |
| Lot numbers | 0317, 1016, 1018, 118, 1216, 1217, 1316, 1317, 1318, 1319, 1418, 1516, 1618, 1718, 1720, 1816, 1817, 190B, 1918, 1919, 1920A, 1920B, 2018, 2117, 2118, 2119, 2216, 2316, 2319, 2416, 2417, 2518A, 2518B, 2619, 2713, 2717, 2718, 2719, 2816, 2818 and 47 more |
| Model numbers | 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 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1518-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.