Ultradent Products, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1368-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 1, 2022

Date Posted: July 20, 2022

Recall Number: Z-1368-2022

Event ID: 90434

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.

Status: Completed

Product Quantity: 1331 Kits (5009 Syringes)

Code Information:

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

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of Florida, Michigan, Nevada, Washington, Colorado, Virginia, Puerto Rico, Wisconsin, Iowa, Tennessee, Arkansas, Minnesota, Wyoming, Maine and the countries of Kuwait, Italy, France, Canada, Spain, Malaysia, Russia, Greece.

Voluntary or Mandated:

Voluntary: Firm initiated