Coltene Whaledent Inc 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Coltene Whaledent Inc
Lot Codes / Batch Numbers
UDI-DI: +ESANS100010 All Serial Numbers
Products Sold
UDI-DI: +ESANS100010 All Serial Numbers
Coltene Whaledent Inc is recalling SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing har due to 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 inh. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Coltene issued Urgent Medical Device Correction to Distributors. The written notification included the Field Safety Notice issued by the manufacturer and the Correction Notice that was issued on January 20th, 202 via Email. Letter states reason for notification, health risk, and action to take: Warning: When using the STATIS SL turbines with REF 2.000.7300 / S10001, with the lack of care or age-related wear and tear, there is a possibility that the push button on the turbine will come loose and this will increase the risk of swallowing or inhaling part of the turbines head or the push button. Recommended action for users: Please urgently observe the following safety instructions from the instructions for use on handling, care and running behaviour of the turbine to protect your patients. This notice needs to be passed on to all those who need to be aware, both within your own organization and in organizations where the potentially affected devices have been transferred. Please ensure that this information and the associated action are followed for a reasonable period of time to ensure the effectiveness of the action.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026