Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Recalled by Ormco/Sybronendo Due to Buchanan Heat Pluggers will possibly overheat while used...

Date: December 27, 2017
Company: Ormco/Sybronendo
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ormco/Sybronendo directly.

Affected Products

Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.

Quantity: 25,765 total

Why Was This Recalled?

Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ormco/Sybronendo

Ormco/Sybronendo has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report