Jiffy composite polisher cups may crumble and break apart easily
Ultradent Products is recalling one lot of Jiffy Original Composite Polisher Cups because the cups may crumble and break apart easily, which could delay patient treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source states the cups can break apart during use and delay patient treatment, and no injuries are stated.
Plain-English summary
Ultradent Products, Inc. is recalling Jiffy Original Composite Polisher Cups (Coarse), 12-pack, REF 7011. About 2,508 units were distributed across 31 US states and Puerto Rico. The FDA has classified this recall as Class II.
The composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
Affected product carries UDI-DI E29270111, lot 529983, with an expiration of 2031-09-02.
Facilities can identify affected cups by the REF, UDI and lot number above, and may contact Ultradent Products, Inc. for further information.
The recalled product
- Product
- Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
- Manufacturer
- Ultradent Products, Inc.
- Affected units
- 2,508
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: E29270111. Lot: 529983. Expiration: 2031-09-02
Distribution
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