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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1689-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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