# FDA recall Z-3015-2026

> **Henry Schein Inc.** · Class II · device recall initiated 2026-07-09.

## 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.

## 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.

## Distribution

Worldwide distribution - US Nationwide and the country of Barbados.

## Key facts

- **Recall number:** Z-3015-2026
- **Recalling firm:** Henry Schein Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-09
- **Report date:** 2026-09-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Denver, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3015-2026

## Citation

> MORVS. FDA recall Z-3015-2026. Retrieved 2026-10-15 from https://api.morvs.ai/recall/Z-3015-2026. Source: US FDA. Licensed CC0.

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