Monarch — Class II medical device recall Z-0025-2020
Terminated recall by AURIS HEALTH INC, reported 2019-11-27, distributed nationwide. Reports of aspirating biopsy needle breakage
| Recall number | Z-0025-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AURIS HEALTH INC, Redwood City, CA, United States |
| Recall initiated | 2019-04-19 |
| Classified | 2019-11-15 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2022-01-19 |
| Distributed | Nationwide (US) |
| Quantity | 158 |
| Reason classes | device malfunction |
| Lot numbers | RS181129-1, RS181129-2, RS181210-1, RS181210-2, RS181210-3, RS181210-4, RS190117-1, RS190125-1, RS190211-1, RS190225-3, RS190308-1, RS190319-1 |
| Model numbers | MBR-000012 |
Product
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Reason for recall
Reports of aspirating biopsy needle breakage
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-0025-2020. 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.