Food, drugs, devices › AURIS HEALTH INC
Device recall: Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
FDA enforcement event 82763 is a device recall by AURIS HEALTH INC of Redwood City, CA, initiated 19 Apr 2019 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 19 Jan 2022. Initiation: voluntary: firm initiated. AURIS HEALTH INC has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
AURIS HEALTH INC, Redwood City, CA.
Reason for recall
"Reports of aspirating biopsy needle breakage"
Distribution
"US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0025-2020 | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 | 158 | Class II | Terminated | 27 Nov 2019 |
Context
Other enforcement events for AURIS HEALTH INC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Jan 2026 | MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000 | Device | Class II | 1 |
| 18 Oct 2025 | MONARCH Bronchoscope. Model Number: MBR-000211-B | Device | Class II | 1 |
| 2 Aug 2024 | Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON- | Device | Class II | 2 |
| 18 Oct 2023 | Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w | Device | Class II | 3 |
All 5 events for AURIS HEALTH INC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Reports of aspirating biopsy needle breakage"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Jan 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.