Reported Nov 27, 2019 · Terminated
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Auris Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AURIS HEALTH INC · 150 Shoreline Dr · Redwood City, CA · 94065-1400
Is this the product you have?
- Monarch, Aspirating Biopsy Needle
- REFMBR-000012, Rx Only
- UDIB634MBR0000120
- Lot codes and dates
- Lots
RS181129-1RS181129-2RS181210-1RS181210-2RS181210-3RS181210-4RS190117-1RS190125-1RS190211-1RS190225-3RS190308-1RS190319-1
- Lots
- Amount recalled
- 158
Where it was sold
Why it was recalled
Reports of aspirating biopsy needle breakage
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Auris Health Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.