Coltene Whaledent recalls SciCan STATIS SL S10001 dental handpieces due to risk of loose turbine parts during use, which could be swallowed or inhaled. All units are affected.
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
Coltene Whaledent is recalling SciCan STATIS SL S10001 dental handpieces because a screw connection may loosen during use, increasing the risk of swallowing or inhaling parts. This could cause serious injury if the parts are inhaled or swallowed.
The screw connecting the turbine head and push button can loosen during dental treatment. If it falls off, parts could be swallowed or inhaled by the patient, leading to serious injury.
Dental professionals using the SciCan STATIS SL S10001 handpieces are affected. Patients during dental procedures are at risk if parts become loose and are swallowed or inhaled.
Check for the model number S10001 on the handpiece. All units are affected, including those with UDI-DI +ESANS100010.
Inspect the turbine head and push button connection for looseness before each use.
Immediately stop using the handpiece if parts feel loose or move unexpectedly.
No, this recall specifically affects SciCan STATIS SL S10001 dental handpieces with model number S10001.
The recall does not provide a specific remedy, so check with the manufacturer for guidance.
Yes, if the turbine head or push button becomes loose and is swallowed or inhaled, it could cause serious injury.
We’ve drafted a message you can send Coltene Whaledent to request your refund or repair — edit it as you like.
Subject: Recall Z-1208-2023 — Coltene Whaledent Coltene Whaledent Hello, I own a Coltene Whaledent that is covered by recall Z-1208-2023 from Coltene Whaledent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
