Z-1368-2022Class II

Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554...

Name: Z-1368-2022 Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554...
Creator: Ultradent Products, Inc.
Published: 2022-06-01
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2022-06-01 / Completed / root cause: design

FDA source

Ultradent Products, Inc. began a recall of 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... on 2022-06-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-1368-2022
Classification: Class II
Status: Completed
Initiated: 2022-06-01
Posted: 2022-07-12
Recalling firm: Ultradent Products Inc.
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.
Product code: KLE Agent, Tooth Bonding, Resin
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1331 Kits (5009 Syringes)
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1368-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1368-2022	Class II	Completed	Voluntary: Firm initiated	2022-07-20	2022-07-12

Product code KLE

K063558Class IIPeak Se, Model 5135Ultradent Products, Inc. / cleared 2006-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)