Ultradent Products, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Ultradent Products, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Ultradent Products, Inc. is recalling Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 06/01/22, recall notices were mailed to customers who were asked to do the following: 1) Discard all primers inside affected devices. 2) Complete and return the recall notice response form. Customers with questions regarding product credit may call Customer Service at 1-888-2301420. Customers with questions or concerns related to the primer can contact Customer Concerns at 801-553-4139.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026