CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report
Structur 2 SC Temporary Resin Cartridge Refill 75Gm recalled
Henry Schein is recalling Structur 2 SC Temporary Resin Cartridge Refill 75Gm, distributed nationwide in the US. The recall was initiated on 9 Jul 2026 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-3015-2026
- FDA event ID
- 99465
- Recalling firm
- Henry Schein, Denver, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jul 2026
- FDA classified
- 25 Aug 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 9 Jul 2026 | Recall initiated by company | |
| 25 Aug 2026 | Classified by FDA | +47 days |
| 2 Sep 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
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
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 1480; Lot 2539064 3) 114-3935, Mfr Product Code 1481; Lot 2533123 4) 114-3937, Mfr Product Code 1482; Lots 2533203, 2607170 is a fluorescent cold polymerizing paste-paste system for the production of temporary crowns, bridges, inlays and onlays.
Where it was distributed
Worldwide distribution - US Nationwide and the country of Barbados.
Questions about this recall
Why was it recalled?
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Which lots are affected?
Product Codes: 1) 114-3933, Mfr Product Code 1479, Lot Numbers: 2536179, 2606429; 2) 114-3934, Mfr Product Code 1480, Lot Numbers: 2539064; 3) 114-3935, Mfr Product Code 1481, Lot Numbers: 2533123; 4) 114-3937, Mfr Product Code 1482, Lot Numbers: 2533203, 2607170.
Where was it sold?
Worldwide distribution - US Nationwide and the country of Barbados.
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.
Other products in this recall event
1 other product · FDA event 99465| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
More recalls from Henry Schein
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
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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 |