FDA Device recall Z-1368-2022
Peak Universal Bond Self-Etch Bottle Kit, Part: 4541
- FDA Device
- Class II
- completed
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Peak Universal Bond Self-Etch Bottle Kit, Part: 4541 by Ultradent Products, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1368-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-06-01 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ultradent Products |
| Distribution | US |
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
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.
Identifiers
| code_info | REF/ UDI-DI/ Lot: 4541/ 00883205104274/ BLRCR, BM1Y7, BM9G3; 4554/ 00883205104281/ BLSGH, BM578, BN449; 5135/ 00883205…REF/ UDI-DI/ Lot: 4541/ 00883205104274/ BLRCR, BM1Y7, BM9G3; 4554/ 00883205104281/ BLSGH, BM578, BN449; 5135/ 00883205104311/ BLX3F, BLSGM, BLXSG, BLXW4, BM34M, BM784, BM9KB, BMJVK, BMTZM; S4554/ 00883205102065/ BLRJJ, BM1NH |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1368-2022%22
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