CLASS II ONGOING Device recall · Reported 8 Mar 2023 · FDA Enforcement Report

SciCan Statis SL S10001 Dental Handpieces-Intended recalled

Coltene Whaledent is recalling SciCan Statis SL S10001 Dental Handpieces-Intended for the removal of carious material, distributed nationwide in the US. The recall was initiated on 20 Jan 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: +ESANS100010 All Serial Numbers

Quantity recalled3896 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1208-2023
FDA event ID: 91601
Recalling firm: Coltene Whaledent, Cuyahoga Falls, OH
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jan 2023
FDA classified: 2 Mar 2023
Reported: 8 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Dental Devices

Timeline

20 Jan 2023	Recall initiated by company
2 Mar 2023	Classified by FDA	+41 days
8 Mar 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: +ESANS100010 All Serial Numbers

Where was it sold?

Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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