Custodiol HTK Solution — Class II medical device recall Z-3300-2024
Ongoing recall by Dr Franz Koehler Chemie Gmbh, reported 2024-10-02, distributed nationwide. Potential for particles to be present in solution.
| Recall number | Z-3300-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr Franz Koehler Chemie Gmbh, Bensheim, Germany |
| Recall initiated | 2024-01-09 |
| Classified | 2024-09-26 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04033133105003 |
| Lot numbers | 2314212, 2320012, 2322812, 2333512 |
Product
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Reason for recall
Potential for particles to be present in solution.
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-3300-2024. 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.