Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Summary
The FDA issued a Class II for Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011. by Ultradent Products, Inc.. Reason: Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment..
Details
Source
Device Recall
External ID
Z-1689-2026
Action Date
2026-04-08
Status
Ongoing
Category
device
Product Description
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Lot/Code Info: UDI-DI: E29270111. Lot: 529983. Expiration: 2031-09-02
Quantity Affected: 2508
Reason for Recall
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-28
Company
South Jordan, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 252 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ultradent Products, Inc. has 12 FDA actions in our database, including 5 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ultradent Products, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ultradent Products, Inc. have FDA actions?
Ultradent Products, Inc. has 12 FDA actions in our database, including 5 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1689-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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