Monarch Aspirating Biopsy Needle (Auris Health) – Needle Breakage (2019)
Biopsy needle can break during medical procedures, potentially causing patient injury.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Brand
AURIS HEALTH INC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
AURIS HEALTH INC is recalling Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 due to Reports of aspirating biopsy needle breakage. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports of aspirating biopsy needle breakage
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026