Auris Health Monarch Biopsy Needle Recall: Breakage Risk

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Contact the company & request your remedy

Recalling firmAURIS HEALTH INC150 Shoreline Dr, N/A · Redwood City, CA 94065-1400

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Auris Health is recalling Monarch aspirating biopsy needles that have reportedly broken. This could cause injury during medical procedures if the needle breaks unexpectedly.

Why it’s dangerous

The needles can break during use, potentially causing injury to the patient or healthcare provider. Breakage may occur without warning, especially during delicate procedures.

Who’s affected

Healthcare professionals using these needles for biopsies are most at risk. Patients receiving these needles under medical supervision may also be affected.

How to tell if you have this one

Check the product label for the reference number MBR-000012 and the lot numbers listed: RS181129-1 through RS190319-1. These needles are only available by prescription.

Brand
Auris Health
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the reference number MBR-000012 and lot numbers RS181129-1 through RS190319-1 on the needle packaging.
Stop Using If Affected
If you have the recalled needles, stop using them immediately and contact Auris Health for instructions.

✎ GovInfoNow

Questions people ask

Why is this needle being recalled?

The recall is due to reports of the Monarch aspirating biopsy needle breaking during use, which could cause injury.

How can I tell if I have the recalled needles?

Check the product label for reference number MBR-000012 and lot numbers RS181129-1 through RS190319-1.

What should I do if I have the recalled needles?

Stop using them immediately and contact Auris Health for instructions on returning or replacing the needles.

Take action

Contact Auris Health

We’ve drafted a message you can send Auris Health to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0025-2020 — Auris Health Auris Health

Hello,

I own a Auris Health that is covered by recall Z-0025-2020 from Auris Health.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0025-2020 (April 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0025-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

AURIS HEALTH INC recalls Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Use caution until it’s fixed