Strauss 25 Carbide Dental Burs — Class II medical device recall Z-0468-2021
Ongoing recall by Coltene Whaledent Inc, reported 2020-11-25, distributed in FL, NV, PA, TN, TX. The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the F
| Recall number | Z-0468-2021 |
|---|---|
| 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 | 2020-10-20 |
| Classified | 2020-11-17 |
| Reported by FDA | 2020-11-25 |
| Distributed | FL, NV, PA, TN, TX |
| Countries outside the US | CA |
| Quantity | 556 |
Product
Strauss 25 Carbide Dental Burs (100057XXV)
Reason for recall
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
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-0468-2021. 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.