Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin — Class II medical device recall Z-1561-2021
Terminated recall by Remel Inc, reported 2021-05-19, distributed nationwide. The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
| Recall number | Z-1561-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2021-04-22 |
| Classified | 2021-05-12 |
| Reported by FDA | 2021-05-19 |
| Terminated | 2023-08-08 |
| Distributed | Nationwide (US) |
| Lot numbers | 248035 |
| Expiration dates | 2021-04-27 |
Product
Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.
Reason for recall
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
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-1561-2021. 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.