Ultradent Products, Inc. recalls Jiffy Original Composite Polisher Cups (Coarse) 12pk
Reason for recall
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF7011UDI-DI E29270111.2 affected lots5299832031-09-02
What the firm is doing
On 1/28/2026, correction notices were mailed to Doctors who were asked to do the following: - Discard affected polisher cups. - Complete and return the response form via email to regulatory.compliance@ultradent.com If you have any concerns or questions related to your replacement product or product use, please contact the firm's customer service at 1-888-230-1420.
DistributionShow detailsHide
US: MA, WI, ME, AL, NY, MN, CA, KY, IL, WY, WA, OH, PR, CT, OR, NJ, MI, NC, HI, PA, NE, TX, UT, NV, LA, VA, MO, FL, AZ, WV, IA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1689-2026
- FDA device classification · EHJOfficial FDA classification for this device type
- CFR regulation · 21 CFR 872.6010The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Ultradent Products, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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