Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1689-2026Class II

Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011

Ultradent Products Inc. / initiated 2026-01-28 / Open, Classified / root cause: manufacturing process

Ultradent Products, Inc. began a recall of Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011 on . FDA classified it as Class II and gives the reason as "Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1689-2026
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Ultradent Products Inc.
Product
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Product code
EHJ Disk, Abrasive
Reason for recall
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
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 [email protected] 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.
Quantity in commerce
2508
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.
Product codes and lots
UDI-DI: E29270111. Lot: 529983. Expiration: 2031-09-02

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1689-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1689-2026Class IIOngoingVoluntary: Firm initiated