Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SybronEndo Elements Obturation Unit Recalled by Ormco/Sybronendo Due to A recall has been issued by SybronEndo because...
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
SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.
Quantity: 3615 units total
Why Was This Recalled?
A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ormco/Sybronendo
Ormco/Sybronendo has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report