SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of… — Class II medical device recall Z-1208-2023
Ongoing recall by Coltene Whaledent Inc, reported 2023-03-08, distributed nationwide. Screw connection between the turbine head and the push button may loosen and fall off during the treatment, an
| Recall number | Z-1208-2023 |
|---|---|
| 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 | 2023-01-20 |
| Classified | 2023-03-02 |
| Reported by FDA | 2023-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, ID, IE, LB, TR |
| Quantity | 3,896 units |
| Model numbers | S10001 |
Product
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001
Reason for recall
Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
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-1208-2023. 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.