Coltene Whaledent Inc: Medical Device Recall in 2023 - (Recall #: Z-1208-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 20, 2023

Date Posted: March 8, 2023

Recall Number: Z-1208-2023

Event ID: 91601

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

Status: Ongoing

Product Quantity: 3896 units

Code Information:

UDI-DI: +ESANS100010 All Serial Numbers

Distribution Pattern:

Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey

Voluntary or Mandated:

Voluntary: Firm initiated