FDA Medical devices recall ·
Structur 2 SC Temporary Resin Cartridge Refill 75Gm… recall
- Recall number
- Z-3015-2026
- Date
- (initiated July 9, 2026)
- Company / brand
- Henry Schein Inc.
41 Weaver Rd, Denver, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 121 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Worldwide distribution - US Nationwide and the country of Barbados.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3015-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.