HYGENIC Wingless Fiesta Kit — Class II medical device recall Z-2422-2020
Ongoing recall by Coltene Whaledent Inc, reported 2020-07-01. Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult fo
| Recall number | Z-2422-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coltene Whaledent Inc, Cuyahoga Falls, OH, United States |
| Recall initiated | 2020-06-03 |
| Classified | 2020-06-23 |
| Reported by FDA | 2020-07-01 |
| Quantity | 7,206 forceps |
| Lot numbers | 1903, 1904, 1906, 1907, 1909, 1910, 1911, 1915, 1920, 1921, 1923, 1927, 1928, 1930, 1934, 1940, J74184, J74546 |
| Model numbers | H02790 |
Product
HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Reason for recall
Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
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-2422-2020. 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.