Potassium Hydroxide 10% — Class II medical device recall Z-2450-2021
Terminated recall by Gibson Bioscience, reported 2021-09-22, distributed in CA, CO, KY, ME, NC, NY, SC. A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
| Recall number | Z-2450-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gibson Bioscience, Lexington, KY, United States |
| Recall initiated | 2021-07-01 |
| Classified | 2021-09-10 |
| Reported by FDA | 2021-09-22 |
| Terminated | 2023-05-02 |
| Distributed | CA, CO, KY, ME, NC, NY, SC |
| Quantity | 11 kits |
| UPC / GTIN / UDI-DI | 10634853000633 |
| Lot numbers | 21137116 |
| Model numbers | 300145 |
Product
Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for direct microscopic observation.
Reason for recall
A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
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-2450-2021. 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.