Cosmedent FlexiCup Composite Finishing & Polishing System — Class II medical device recall Z-0211-2024
Ongoing recall by Cosmedent, Inc., reported 2023-11-08, distributed nationwide. Reports were received the elastomer cup material is crumbling.
| Recall number | Z-0211-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cosmedent, Inc., Chicago, IL, United States |
| Recall initiated | 2023-07-20 |
| Classified | 2023-11-02 |
| Reported by FDA | 2023-11-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CO, DK, EC, EE, ES, GB, GR, HU, IL, IR, JP, LT, MX, NL, NZ, PH, PY, SE |
| Lot numbers | 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, 484781 |
| Model numbers | 403-101 |
Product
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Reason for recall
Reports were received the elastomer cup material is crumbling.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0211-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.