Blood/EMB — Class II medical device recall Z-2225-2025
Ongoing recall by Remel, Inc, reported 2025-08-06, distributed nationwide. The products may contain surface and subsurface contamination of Listeria monocytogenes.
| Recall number | Z-2225-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel, Inc, Lenexa, KS, United States |
| Recall initiated | 2025-07-11 |
| Classified | 2025-07-31 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 750 units |
| Reason classes | microbial contamination |
| Pathogens | listeria monocytogenes |
| UPC / GTIN / UDI-DI | 00848838003684 |
| Lot numbers | 274194 |
Product
Blood/EMB, Levine 100/PK, Product Number R02041
Reason for recall
The products may contain surface and subsurface contamination of Listeria monocytogenes.
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-2225-2025. 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.