remel BLOOD AGAR EMB AGAR BIPLATE — Class II medical device recall Z-1201-2025
Ongoing recall by Remel, Inc, reported 2025-02-26, distributed nationwide. Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible
| Recall number | Z-1201-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel, Inc, Lenexa, KS, United States |
| Recall initiated | 2025-02-13 |
| Classified | 2025-02-20 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 316 units |
| Reason classes | microbial contamination |
| Pathogens | listeria monocytogenes |
| UPC / GTIN / UDI-DI | 00848838003684 |
| Lot numbers | 213971 |
| Model numbers | 100, R02041 |
| Expiration dates | 2025-02-25 |
Product
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Reason for recall
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
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-1201-2025. 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.