FDA Medical Device Recalls (openFDA)
AURIS HEALTH INC: Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
- Recall number
- Z-0025-2020
- Recalling firm
- AURIS HEALTH INC
- Product
- Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
- Status
- Terminated
- Initiated
- 2019-04-19
- Posted
- not on file
- Terminated
- 2022-01-19
- Reason
- Reports of aspirating biopsy needle breakage
- Root cause
- Labeling design
- Action
- On 04/19/19, Urgent Medical Device Notifications were mailed to customers. Customers were advised the following: Please review the updated instructions for use for proper insertion, along with updated and warnings/cautions related to the use of the device. Specifically, the following instructions were included: " Do NOT use excessive insertion force if resistance is encountered during insertion of the needle through the bronchoscope working channel. Excessive force may cause damage to either the device or the bronchoscope working channel. " DO inspect the needle sharp for damage prior to use. If damage is found, do not use the needle. " Do NOT use the needle if the bronchoscope working channel is damaged, kinked or compromised. Please ensure that all necessary personnel in your facility are made aware of this notification, and please maintain awareness on this notice to ensure effectiveness of the corrective action. Complete and return the Acknowledgement Form. Customers with questions are encouraged to call 1-800-434-0032. On 06/25/19, Urgent Medical Device Recall (Removal) notices were mailed to customers informing them that the recalling firm is in the process of investigating the root cause and they will contact customers when replacement product becomes available. In the meantime, refer to the Compatibility Statement in the User Manual when deciding to use other commercially available needles. Customers were advised: 1.Examine your inventory immediately to determine if you have product lots subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product lots subject to this recall (removal) and communicate the issue to relevant personnel, or anyone else in your facility who needs to be informed. 3. If any product lots subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. 4. Complete the attached Acknowledgement Form confirming receipt of this notice an
- Quantity
- 158
- Distribution
- US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K173760"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 3014447948
- Firm city
- Redwood City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28