SybronEndo Recalls Sealapex Xpress Root Canal Resin Due to Labeling Error
SybronEndo is recalling 179 units of Sealapex Xpress root canal filling resin because the product was labeled with an incorrect expiration date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the source text identifies the issue as a labeling error regarding the expiration date. This aligns with the rubric criterion for minor labeling errors.
Plain-English summary
SybronEndo is recalling 179 units of Sealapex Xpress, a root canal filling resin used during endodontic therapy. The recall was initiated because the product was labeled with an incorrect expiration date of 2017-11, while the syringe itself was correctly labeled with an expiration date of 2016-11.
The affected product is identified by lot number 5-1310. The units were distributed nationwide in the United States and in Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
Consumers and healthcare providers should stop using the affected units and contact SybronEndo for further instructions or a return.
The recalled product
- Product
- Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
- Manufacturer
- Ormco/Sybronendo
- Hazard
- Affected units
- 179
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 (1)
- lot # 5-1310
Distribution
Distributed nationwide across the United States.
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