CLASS II Device recall · Reported 28 Sep 2016 · FDA Enforcement Report
Sealapex Xpress recalled by Ormco/Sybronendo
Ormco/Sybronendo is recalling Sealapex Xpress, distributed nationwide in the US. The recall was initiated on 31 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2836-2016
- FDA event ID
- 75114
- Recalling firm
- Ormco/Sybronendo, Glendora, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Aug 2016
- FDA classified
- 16 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 31 Aug 2016 | Recall initiated by company | |
| 16 Sep 2016 | Classified by FDA | +16 days |
| 28 Sep 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
lot # 5-1310
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ormco/Sybronendo
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ormco Damon Q2 Orthodontic Metal Bracket recalled by Ormco/Sybronendo | Ormco/Sybronendo | Labeling Errors | Nationwide |
| Device | CLASS II | SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022 recalled | Ormco/Sybronendo | Device Malfunction | 51 states |
| Device | CLASS II | SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022 recalled | Ormco/Sybronendo | Device Malfunction | 51 states |
| Device | CLASS II | Elements Obturation Unit (EOU) used recalled by Ormco/Sybronendo | Ormco/Sybronendo | Other | Nationwide |
| Device | CLASS II | TF Adaptive Gutta Percha Point Size SM3 recalled by Ormco/Sybronendo | Ormco/Sybronendo | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |