Class 2 Device Recall Jiffy

• Date Initiated by Firm: January 28, 2026
• Date Posted: March 27, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1689-2026
• Recall Event ID: 98419
• Product Classification: Disk, abrasive - Product Code EHJ
• Product: Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
• Code Information: UDI-DI: E29270111. Lot: 529983. Expiration: 2031-09-02
• FEI Number: 1718912
• Recalling Firm/ Manufacturer: Ultradent Products, Inc.; 505 W 10200 S; South Jordan UT 84095-3800
• For Additional Information Contact: Emma Gillespie; 801-553-4127
• Manufacturer Reason for Recall: Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
• FDA Determined 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 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.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.