Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

FDA Recall Z-1361-2026 · Posted 2026-02-12

Recalling FirmSteris Corporation
Recall StatusOpen, Classified
Product CodeKQM
Date Initiated2025-05-23
Product Quantity10 units

Reason for Recall

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.

Firm Action

All affected Customers have been contacted by a STERIS Service Technician arranging an onsite inspection of their unit(s) to locate and replace the affected MNA(s). Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact Diksha Chechi, Quality Manager at 510-439-4500.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑