IonoStar Plus — Class II medical device recall Z-1142-2024
Ongoing recall by Voco GmbH, reported 2024-02-28, distributed in IA, NY, PA, WA. Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some
| Recall number | Z-1142-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Voco GmbH, Cuxhaven, N/A, Germany |
| Recall initiated | 2024-01-25 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Distributed | IA, NY, PA, WA |
| Countries outside the US | AU, BE, BG, CA, CH, CZ, DE, DK, ES, FR, GB, GR, IE, IN, IT, LT, NL, NO, PL, PT, RO, SA, SE, SK |
| Quantity | 1,530 units |
| Lot numbers | 2338699, 2342759, 2342760, 2344016, 2344045, 2344046, 2344047, 2347154, 2348503, 2349452, 2349453, 2351233, 2439537 |
| Model numbers | 2540, 2544, 2545, 2546, 2547, 2549 |
Product
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Reason for recall
Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
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-1142-2024. 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.