Food, drugs, devices › Coltene Whaledent Inc
Device recall: SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, c
Coltene Whaledent Inc (Cuyahoga Falls, OH) initiated this device recall on 20 Jan 2023; FDA lists 1 product record under event 91601, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Coltene Whaledent Inc has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Coltene Whaledent Inc, Cuyahoga Falls, OH.
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"
Distribution
"Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1208-2023 | 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 | 3896 units | Class II | Ongoing | 8 Mar 2023 |
Context
Other enforcement events for Coltene Whaledent Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Mar 2021 | Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental rest | Device | Class II | 1 |
| 20 Oct 2020 | Alpen Clinic 100 Carbide Instruments (R100057C) | Device | Class II | 5 |
| 3 Jun 2020 | HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunct | Device | Class II | 4 |
| 21 Aug 2018 | ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into | Device | Class II | 1 |
| 13 Apr 2018 | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from c | Device | Class II | 1 |
| 11 Dec 2013 | Latex Dental Dams labeled as Non-Latex Dental Dams | Device | Class II | 1 |
All 7 events for Coltene Whaledent Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.