Z-0025-2020 Class II Terminated
FDA device recall Z-0025-2020 was initiated by AURIS HEALTH INC on Apr 19, 2019 and is designated Class II. Reason for recall: Reports of aspirating biopsy needle breakage The recall status is terminated (terminated Jan 19, 2022). Affected quantity: 158.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 27, 2019
- Initiation Date
- Apr 19, 2019
- Termination Date
- Jan 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 158
Product Description
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Reason for Recall
Reports of aspirating biopsy needle breakage
Distribution Pattern
US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0025-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026