FDA Medical devices recall ·
Monarch Platform (Urology) recall
- Recall number
- Z-0052-2025
- Date
- (initiated August 2, 2024)
- Company / brand
- Auris Health, Inc
150 Shoreline Dr, Redwood City, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4
- Hazard tags
- Electrical shock
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Why was it recalled?
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 or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Cart Power Cord 20' 14AWG BLK, PN 304-003613-00. Tower Power Cord 20' 14AWG BLK, PN 304-003607-00. REF/UDI-DI/Serial Numbers: MON-000007/+B634MON0000070/120059, 120133, 210002; MON-000007-RFB/10810068810889/210001.
Distribution
Worldwide - US Nationwide distribution including in the states of MN, FL, NC, AK, NJ, NY, VA, WI, AZ, MS, LA, MI, MA, MT, WV, GA, DE, TX, CA, OH, IN, SC, PA, CT, ND, MO, DC, IL, NE, ID, WA, TN, OR, AL, SD, CO, KY, NM, VT, MD and the countries of Canada.
States: Alaska Alabama Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Idaho Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Jersey New Mexico New York Ohio Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Virginia Vermont Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0052-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.