SybronEndo Recalls Dental Power Cords Due to Missing Safety Label
SybronEndo is recalling 3,615 Elements Obturation Unit power cords because a required Canadian safety label was accidentally omitted from the packaging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes the issue as an inadvertently omitted cautionary label without reporting any injuries, illnesses, or specific functional defects. This aligns with the rubric for moderate severity involving labeling errors or precautionary measures.
Plain-English summary
SybronEndo is recalling 3,615 units of the Replacement AC Power Cord for the Elements Obturation Unit. The recall was issued because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the product.
The affected product is the SybronEndo Replacement AC Power Cord (REF 973-0334), which is used to provide continuous heat for dental procedures such as testing tooth response to thermal stimulus and backfilling gutta percha. The units were distributed worldwide, including in the United States, Canada, and numerous other countries.
The specific lot and serial numbers affected by this recall are 3757349, 4220920, 4304917, 4367699, 436513, 4445719, 4458262, 4522605, 4581118, 4724407, and 4730212. Consumers and dental professionals should check their inventory for these specific serial numbers and contact SybronEndo for instructions on how to proceed.
The recalled product
- Product
- SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan The intended use of the Elements Obturation Unit and R
- Manufacturer
- Ormco/Sybronendo
- Hazard
- Affected units
- 3,615
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot/Serial Numbers: 3757349
- 4220920
- 4304917
- 4367699
- 436513
- 4445719
- 4458262
- 4522605
- 4581118
- 4724407
- 4730212
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ormco/Sybronendo under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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