1 — Class II medical device recall Z-0585-2026
Ongoing recall by Remel, Inc, reported 2025-12-03, distributed nationwide. Products may contain contamination, which may result in a darker or brown media color.
| Recall number | Z-0585-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel, Inc, Lenexa, KS, United States |
| Recall initiated | 2025-11-12 |
| Classified | 2025-11-21 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CN, CY, FI, GB, IE, NO, SG |
| UPC / GTIN / UDI-DI | 00848838018831, 00848838091353 |
| Lot numbers | 305529, 311228, 316019, 317287, 320993 |
Product
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Reason for recall
Products may contain contamination, which may result in a darker or brown media color.
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-0585-2026. 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.