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.
Other recalls by Ultradent Products
- Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011
FDA Device · Class II · 2026-04-08 · Ultradent Products - Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit…
FDA Device · Class II · 2024-09-18 · Ultradent Products - Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Descriptio…
FDA Device · Class II · 2024-09-18 · Ultradent Products - Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Pro…
FDA Device · Class II · 2024-09-18 · Ultradent Products - PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite
FDA Device · Class II · 2020-10-14 · Ultradent Products
All Ultradent Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1368-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.