FDA Medical Device Recalls (openFDA)
Ultradent Products, Inc.: Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
- Recall number
- Z-1689-2026
- Recalling firm
- Ultradent Products, Inc.
- Product
- Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
- Status
- Open, Classified
- Initiated
- 2026-01-28
- Posted
- 2026-03-27
- Terminated
- not on file
- Reason
- Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
- 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 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
- 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.
- Lot, serial or model codes
- UDI-DI: E29270111. Lot: 529983. Expiration: 2031-09-02
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EHJ
- Firm FEI
- 1718912
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28