FDA Medical devices recall ·
Barco MNA with the HexaVue IP Integration System, Model recall
- Recall number
- Z-1361-2026
- Date
- (initiated May 23, 2025)
- Company / brand
- Steris Corporation
5960 Heisley Rd, Mentor, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Why was it recalled?
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
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
UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829
Distribution
US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
States: Florida North Carolina New York Ohio Tennessee Texas 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-1361-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.