The Recall Desk
HighFDA (Devices)·Z-1368-2022·Announced 2022-07-20

Dental bonding primer may lack resin component affecting restoration

Ultradent Peak Universal Bond self-etch dental primers may be missing resin, potentially compromising bond strength. Affected products were distributed nationwide and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with no reported hospitalizations or injuries. The recall addresses a risk-of-harm product (dental bonding integrity) where injury has not yet been reported, meeting the criterion for Score 3 per the severity rubric.

Plain-English summary

Ultradent Products, Inc. is recalling specific lots of Peak Universal Bond Self-Etch dental bonding products, including the Bottle Kit (Part 4541), Intro Kit (Part 4554), SE Primer Refill (Part 5135), and Sample Kit (Part S4554). These products are used by dentists for light-curing dental bonding procedures. The recall affects 1,331 kits comprising 5,009 syringes.

The recalled products may be missing the resin component of the self-etch primer chemistry. This defect could compromise bond strength and affect the integrity of dental restorations.

The products were distributed worldwide. In the United States, distribution included Florida, Michigan, Nevada, Washington, Colorado, Virginia, Puerto Rico, Wisconsin, Iowa, Tennessee, Arkansas, Minnesota, Wyoming, and Maine. International distribution included Kuwait, Italy, France, Canada, Spain, Malaysia, Russia, and Greece.

Dentists who have received affected products should verify lot numbers against the recall list. Products matching the affected lot numbers (BLRCR, BM1Y7, BM9G3 for Part 4541; BLSGH, BM578, BN449 for Part 4554; BLX3F, BLSGM, BLXSG, BLXW4, BM34M, BM784, BM9KB, BMJVK, BMTZM for Part 5135; and BLRJJ, BM1NH for Part S4554) should not be used. Contact Ultradent Products, Inc. for replacement or further instructions.

The recalled product

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.
Manufacturer
Ultradent Products, Inc.
Category
Medical Device — Dental Bonding
Hazard
  • improper-bonding
  • missing-component

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • 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

Distributed nationwide across the United States.

Related recalls

Same category