Peak Universal Bond Self-Etch Bottle Kit — Class II medical device recall Z-1368-2022
Completed recall by Ultradent Products, Inc., reported 2022-07-20, distributed nationwide. SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bo
| Recall number | Z-1368-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultradent Products, Inc., South Jordan, UT, United States |
| Recall initiated | 2022-06-01 |
| Classified | 2022-07-12 |
| Reported by FDA | 2022-07-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, ES, FR, GR, IT, KW, MY, RU |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00883205102065, 00883205104274, 00883205104281, 00883205104311 |
| Lot numbers | 4541 |
| Model numbers | 4541, 4554, 5135, S4554 |
Product
Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
Reason for recall
SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
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-1368-2022. 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.