CLASS II Device recall · Reported 20 Jul 2022 · FDA Enforcement Report
Peak Universal Bond Self-Etch Bottle Kit, Part recalled
Ultradent Products is recalling Peak Universal Bond Self-Etch Bottle Kit, Part: 4541, distributed nationwide in the US. The recall was initiated on 1 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1368-2022
- FDA event ID
- 90434
- Recalling firm
- Ultradent Products, South Jordan, UT
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 1 Jun 2022
- FDA classified
- 12 Jul 2022
- Reported
- 20 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 1 Jun 2022 | Recall initiated by company | |
| 12 Jul 2022 | Classified by FDA | +41 days |
| 20 Jul 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArkansasColoradoFloridaIowaMaineMichiganMinnesotaNevadaPuerto RicoTennesseeVirginiaWashingtonWisconsinWyoming
Questions about this recall
Is Peak Universal Bond Self-Etch Bottle Kit, Part: 4541 recalled?
Yes. Ultradent Products recalled Peak Universal Bond Self-Etch Bottle Kit, Part: 4541 on 1 Jun 2022. The recall is Class II and its status is Completed. Recall number Z-1368-2022.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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