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Coltene Whaledent Inc

Complete recall history across all FDA and CPSC categories — 14 total recalls

Coltene Whaledent Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (14)

FDA medical device enforcement actions by Coltene Whaledent Inc

Date Product Reason Class
Jan 20, 2023 SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious... Screw connection between the turbine head and the push button may loosen and ... Class II
Mar 18, 2021 Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted in... The incorrect dental pins were packaged and subsequently distributed. Class II
Oct 20, 2020 Strauss 25 Carbide Dental Burs (100057XXV) The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs wil... Class II
Oct 20, 2020 Clinic Pack 100 Pieces FG 57 100057C (100057C) The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs wil... Class II
Oct 20, 2020 Alpen Clinic 100 Carbide Instruments (R100057C) The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs wil... Class II
Oct 20, 2020 FG 57 100057X (100057X) The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs wil... Class II
Oct 20, 2020 CEI Cutting Edge Instruments (PTC-57C) The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs wil... Class II
Jun 3, 2020 HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam fo... Multiple Coltene batches of the product have a pin size larger than acceptabl... Class II
Jun 3, 2020 HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam ... Multiple Coltene batches of the product have a pin size larger than acceptabl... Class II
Jun 3, 2020 HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam f... Multiple Coltene batches of the product have a pin size larger than acceptabl... Class II
Jun 3, 2020 HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam... Multiple Coltene batches of the product have a pin size larger than acceptabl... Class II
Aug 21, 2018 ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catal... ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 Class II
Apr 13, 2018 Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model ... The products are labeled with an incorrect product number. Class II
Dec 11, 2013 Latex Dental Dams labeled as Non-Latex Dental Dams Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the i... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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