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 SciCan STATIS SL S10001 Dental Handpieces Recall: Loose Parts Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59023-coltene-whaledent-scican-statis-sl-s10001-dental-handpieces-recall-loose. Based on FDA recall #Z-1208-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1208-2023%22&limit=1).
Coltene Whaledent Inc is voluntarily recalling SciCan STATIS SL S10001 Dental Handpieces due to a screw connection hazard that may loosen and fall off during treatment, according to the FDA. The Food and Drug Administration announced the recall on Jan. 20, 2023.
The screw connection between the turbine head and the push button may loosen and fall off during treatment, increasing the risk of swallowing or inhaling parts of the turbine head or the push button. The FDA said the handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and polishing teeth.
Context
GovInfoNow's records show Coltene Whaledent Inc has five other recalls on record since April 13, 2018. Other recent recalls of similar products include the Canon Alphenix INFX-8000F X-Ray System Recall (Dec. 19, 2025), the Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026), and the Canon Alphenix X-ray Systems Recall (Aug. 4, 2026).
How to tell if you have this one
Check for the model number S10001 on the handpiece. All units are affected, including those with UDI-DI +ESANS100010.
Brand
Coltene Whaledent
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Loose Parts
Inspect the turbine head and push button connection for looseness before each use.
Stop Using if Loose
Immediately stop using the handpiece if parts feel loose or move unexpectedly.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1208-2023 (January 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1208-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.