Sealapex Xpress — Class II medical device recall Z-2836-2016
Terminated recall by Ormco/Sybronendo, reported 2016-09-28, distributed nationwide. SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-1
| Recall number | Z-2836-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ormco/Sybronendo, Glendora, CA, United States |
| Recall initiated | 2016-08-31 |
| Classified | 2016-09-16 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2017-09-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, DE, DK, GB, MX, SE |
| Quantity | 179 units |
| Reason classes | labeling |
| Lot numbers | 5-1310 |
| Model numbers | 33639 |
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.
Reason for recall
SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2836-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.