Food, drugs, devices › Auris Health, Inc
Device recall: MONARCH Bronchoscope. Model Number: MBR-000211-B
FDA enforcement event 97781 is a device recall by Auris Health, Inc of Santa Clara, CA, initiated 18 Oct 2025 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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. 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, Santa Clara, CA.
Reason for recall
"Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks."
Distribution
"Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA, MI, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, VA, VT, WA, WV."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0543-2026 | MONARCH Bronchoscope. Model Number: MBR-000211-B | 1,477 units | Class II | Ongoing | 26 Nov 2025 |
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 |
| 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 |
| 19 Apr 2019 | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 | Device | Class II | 1 |
All 5 events for Auris Health, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks."
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: "Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA, MI, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, VA, VT, WA, WV."
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.