Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of Recalled by Coltene Whaledent Inc Due to Screw connection between the turbine head and the...

Date: January 20, 2023
Company: Coltene Whaledent Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Coltene Whaledent Inc directly.

Affected Products

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

Quantity: 3896 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Coltene Whaledent Inc

Coltene Whaledent Inc has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report