BD BBL Martin-Lewis Agar — Class II medical device recall Z-1377-2021
Terminated recall by Becton Dickinson & Co., reported 2021-04-14, distributed nationwide. Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reactio
| Recall number | Z-1377-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2021-03-17 |
| Classified | 2021-04-08 |
| Reported by FDA | 2021-04-14 |
| Terminated | 2022-08-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, KR |
| Quantity | 15,550 units |
| UPC / GTIN / UDI-DI | 30382902215586 |
| Lot numbers | 0317559, 0345695, 2021-APR-06, 2021-MAR-11 |
| Model numbers | 221558 |
Product
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
Reason for recall
Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment
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-1377-2021. 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.