Manufacturer

Coltene Whaledent Inc

14 recalls in our database name Coltene Whaledent Inc as the manufacturing or recalling firm.

What the numbers show

Total: 14
Critical: 0
Severe: 0
Most recent: 2023-03-08

Of the 14 recalls from Coltene Whaledent Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

HighFDA (Devices)·Z-1208-2023·2023-03-08
Dental Handpieces Recalled Due to Detachable Screw Component Risk
Coltene Whaledent Inc is recalling SciCan STATIS SL S10001 dental handpieces because the screw connection between the turbine head and push button may loosen and fall off, creating a risk of swallowing or inhaling these parts.
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1494-2021·2021-05-05
Coltene Whaledent Recalls TMS LINK PLUS Self-Threading Dental Pins
Coltene Whaledent Inc is recalling TMS LINK PLUS Self-Threading Dental Pins because incorrect pins were packaged and distributed. The recall affects 65 packs of 20 pins.
Product
Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0467-2021·2020-11-25
Coltene Whaledent Recalls CEI Cutting Edge Instruments Due to Packaging Error
Coltene Whaledent is recalling 556 CEI Cutting Edge Instruments (PTC-57C) because FG 557 burs were incorrectly packaged as FG 57 burs, which may remove more material.
Product
CEI Cutting Edge Instruments (PTC-57C)
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0466-2021·2020-11-25
Coltene Whaledent FG 57 Dental Burs Recalled Due to Packaging Error
Coltene Whaledent is recalling FG 57 dental burs that were incorrectly packaged as FG 557 burs, which remove more material.
Product
Clinic Pack 100 Pieces FG 57 100057C (100057C)
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0464-2021·2020-11-25
Coltene Whaledent Recalls Mispackaged Alpen Clinic 100 Carbide Instruments
Coltene Whaledent Inc is recalling 556 packs of Alpen Clinic 100 Carbide Instruments because FG 557 burs were incorrectly packaged as FG 57 burs.
Product
Alpen Clinic 100 Carbide Instruments (R100057C)
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0468-2021·2020-11-25
Strauss 25 Carbide Dental Burs Recalled for Incorrect Packaging
Coltene Whaledent Inc is recalling Strauss 25 Carbide Dental Burs because they were incorrectly packaged as a different model, posing a risk of excessive material removal.
Product
Strauss 25 Carbide Dental Burs (100057XXV)
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0465-2021·2020-11-25
Coltene Whaledent FG 57 Dental Burs Recalled for Packaging Error
Coltene Whaledent is recalling 556 FG 57 dental burs that were incorrectly packaged as FG 557 burs, which remove more material.
Product
FG 57 100057X (100057X)
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-2422-2020·2020-07-01
Coltene Recalls Dental Dam Forceps Due to Pin Size Defect
Coltene Whaledent Inc is recalling 7,206 HYGENIC Wingless Fiesta Kit forceps because a pin size defect may prevent them from fitting dental dam clamps.
Product
HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2419-2020·2020-07-01
Coltene Recalls HYGENIC Dental Dam Forceps Due to Pin Size Defect
Coltene Whaledent Inc is recalling 7,206 HYGENIC Dental Dam Forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.
Product
HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2420-2020·2020-07-01
Coltene Recalls HYGENIC Simple Dam Kit Forceps Due to Fit Issues
Coltene Whaledent Inc is recalling 7,206 HYGENIC Simple Dam Kit forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.
Product
HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2421-2020·2020-07-01
Coltene Recalls Dental Dam Forceps Due to Pin Size Defect
Coltene Whaledent Inc is recalling 7,206 dental dam forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.
Product
HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0376-2019·2018-11-14
Coltene Whaledent Recalls ParaPost Plus Titanium Dental Posts
Coltene Whaledent Inc is recalling ParaPost Plus 25 Titanium Alloy dental posts because they contain stainless steel posts that are a size 4.
Product
ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to…
Category
Medical Device
Distribution
6 states
LowFDA (Devices)·Z-1883-2018·2018-05-23
Coltene Whaledent Recalls Carbide Burs Due to Incorrect Product Number Labeling
Coltene Whaledent Inc is recalling 11 packs of Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack carbide burs because they are labeled with an incorrect product number.
Product
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2151-2014·2014-08-13
Coltene Whaledent Recalls Latex Dental Dams Labeled as Non-Latex
Coltene Whaledent Inc. is recalling latex dental dams that were incorrectly packaged in non-latex packaging, posing a risk to patients with latex allergies.
Product
Latex Dental Dams labeled as Non-Latex Dental Dams
Category
Medical Device
Distribution
0 states