Auris Health, Inc recalls MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left…
Read the official notice →- Date
- 2026-02-25
- Country
- United States
- Brand
- Auris Health
- Product
- MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of MN, FL, NJ, NY, VA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
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- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Auris Health recalls
- 2025-11-26
USAuris Health, Inc recalls MONARCH Bronchoscope. Model Number: MBR-000211-B
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
FDA · DeviceAuris Health, IncNationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA,…Official notice →- 2024-10-16
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AURIS HEALTH INC recalls Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure…
FDA · DeviceAURIS HEALTH INCWorldwide - US Nationwide distribution including in the states of MN, FL, NC,…Official notice → - 2023-12-13
- US
AURIS HEALTH INC recalls Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
FDA · DeviceAURIS HEALTH INCUS Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI,…Official notice →
Other drugs & medical recalls in the United States
- 2026-02-25
- US
Stryker Corporation recalls MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009…
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Products were mislabeled as the 6mm product but included the 5 mm product.
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Medline Industries, LP recalls Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:…
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Olympus Corporation of the Americas recalls Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
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Medica Corporation recalls Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
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Immunotech A.S. recalls Estrone RIA, REF: DSL8700
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