FDA Device recall Z-0025-2020
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
- FDA Device
- Class II
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 by Auris Health, citing reports of aspirating biopsy needle breakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0025-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-19 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Auris Health |
| Distribution | US |
Product
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Reason
Reports of aspirating biopsy needle breakage
Identifiers
| code_info | Lots: RS181129-1 RS181129-2 RS181210-1 RS181210-2 RS181210-3 RS181210-4 RS190117-1 RS190125-1 RS190211-1 RS190225-3 RS190308-1 RS190319-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Auris Health
- MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Device · Class II · 2026-02-25 · Auris Health - MONARCH Bronchoscope
FDA Device · Class II · 2025-11-26 · Auris Health - Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
FDA Device · Class II · 2024-10-16 · Auris Health - Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB
FDA Device · Class II · 2024-10-16 · Auris Health - Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
FDA Device · Class II · 2023-12-13 · Auris Health
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0025-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.