CLASS II Device recall · Reported 27 Nov 2019 · FDA Enforcement Report

Monarch, Aspirating Biopsy Needle recalled by Auris Health

Auris Health is recalling Monarch, Aspirating Biopsy Needle, distributed nationwide in the US. The recall was initiated on 19 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: RS181129-1 RS181129-2 RS181210-1 RS181210-2 RS181210-3 RS181210-4 RS190117-1 RS190125-1 RS190211-1 RS190225-3 RS190308-1 RS190319-1

Quantity recalled158

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0025-2020
FDA event ID: 82763
Recalling firm: Auris Health, Redwood City, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 Apr 2019
FDA classified: 15 Nov 2019
Reported: 27 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Syringes & Needles

Timeline

19 Apr 2019	Recall initiated by company
15 Nov 2019	Classified by FDA	+210 days
27 Nov 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reports of aspirating biopsy needle breakage

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Where it was distributed

US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.

Nationwide California Connecticut Florida Illinois Michigan Minnesota Mississippi Ohio Oklahoma Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

Reports of aspirating biopsy needle breakage

Which lots are affected?

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

Where was it sold?

US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Auris Health

All 8

Reported	Class	Recall	Company	Reason	Where
25 Feb 2026Device	CLASS II	Monarch Platform, Bronchoscopy recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
26 Nov 2025Device	CLASS II	Monarch Bronchoscope recalled by Auris Health	Auris Health	Packaging Defects	Nationwide
16 Oct 2024Device	CLASS II	Monarch Platform (Urology) recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
16 Oct 2024Device	CLASS II	Monarch Platform (Endoscopy) recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
13 Dec 2023Device	CLASS II	Monarch Platform recalled by Auris Health	Auris Health	Device Malfunction	34 states

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