Coltene Whaledent recalls

Coltene Whaledent has 14 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 8 Mar 2023. 11 are still ongoing. The most frequent reason is packaging defects.

Total recalls14since 2014

Last 12 months0reported

Class I00% of total

Ongoing11latest 8 Mar 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 14 100%Class III 0 0%

Why coltene whaledent is recalled

Product types

By year

202317%
202117%
2020964%
2018214%
201417%

Ongoing coltene whaledent recalls

11 active

Reported	Class	Recall	Company	Reason	Where
8 Mar 2023Device	CLASS II	SciCan Statis SL S10001 Dental Handpieces-Intended recalled	Coltene Whaledent	Other	Nationwide
5 May 2021Device	CLASS II	Dental pins - Tms Link Plus Self-Threading Pins recalled	Coltene Whaledent	Packaging Defects	Nationwide
25 Nov 2020Device	CLASS II	Strauss 25 Carbide Dental Burs (100057XXV) recalled by Coltene Whaledent	Coltene Whaledent	Packaging Defects	5 states
25 Nov 2020Device	CLASS II	Clinic Pack FG 57 100057C (100057C) recalled by Coltene Whaledent	Coltene Whaledent	Packaging Defects	5 states
25 Nov 2020Device	CLASS II	Alpen Clinic 100 Carbide Instruments (R100057C) recalled	Coltene Whaledent	Packaging Defects	5 states
25 Nov 2020Device	CLASS II	Fg 57 100057x (100057x) recalled by Coltene Whaledent	Coltene Whaledent	Packaging Defects	5 states

All coltene whaledent recalls, newest first

14 total

Reported	Class	Recall	Company	Reason	Where
8 Mar 2023Device	CLASS II	SciCan Statis SL S10001 Dental Handpieces-Intended recalled	Coltene Whaledent	Other	Nationwide
5 May 2021Device	CLASS II	Dental pins - Tms Link Plus Self-Threading Pins recalled	Coltene Whaledent	Packaging Defects	Nationwide
25 Nov 2020Device	CLASS II	Strauss 25 Carbide Dental Burs (100057XXV) recalled by Coltene Whaledent	Coltene Whaledent	Packaging Defects	5 states
25 Nov 2020Device	CLASS II	Clinic Pack FG 57 100057C (100057C) recalled by Coltene Whaledent	Coltene Whaledent	Packaging Defects	5 states
25 Nov 2020Device	CLASS II	Alpen Clinic 100 Carbide Instruments (R100057C) recalled	Coltene Whaledent	Packaging Defects	5 states
25 Nov 2020Device	CLASS II	Fg 57 100057x (100057x) recalled by Coltene Whaledent	Coltene Whaledent	Packaging Defects	5 states
25 Nov 2020Device	CLASS II	CEI Cutting Edge Instruments (PTC-57C) recalled by Coltene Whaledent	Coltene Whaledent	Packaging Defects	5 states
1 Jul 2020Device	CLASS II	Hygenic Simple Dam Kit recalled by Coltene Whaledent	Coltene Whaledent	Foreign Material	OH
1 Jul 2020Device	CLASS II	Hygenic Dental Dam Forceps recalled by Coltene Whaledent	Coltene Whaledent	Foreign Material	OH
1 Jul 2020Device	CLASS II	Hygenic Winged Fiesta Kit recalled by Coltene Whaledent	Coltene Whaledent	Foreign Material	OH

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.