3M Unitek Transbond Plus Self-Etching Primer REF 712-090 — Class II medical device recall Z-0797-2025
Ongoing recall by 3M Unitek Corporation, reported 2025-01-08, distributed nationwide. Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
| Recall number | Z-0797-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Unitek Corporation, Monrovia, CA, United States |
| Recall initiated | 2024-11-26 |
| Classified | 2025-01-02 |
| Reported by FDA | 2025-01-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CR, DE, EE, ES, FI, FR, GB, GR, HK, IE, IL, IT, JP, KR, LT, LV, MX, MY, NO, NZ, PL, RO, SE, SG, SI, TR, UA |
| UPC / GTIN / UDI-DI | 00652221109170, 00652221109187 |
| Lot numbers | 11093917, 11106533, 11120254, 11153742, 11155372, 11165780, 11165793, 11173412 |
| Model numbers | 712-090 |
Product
3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.
Reason for recall
Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
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-0797-2025. 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.