Data Foundry

Medical device recalls 2026

Barco MNA with the HexaVue IP Integration System — Class II medical device recall Z-1361-2026

Ongoing recall by Steris Corporation, reported 2026-02-18, distributed nationwide. This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a

Recall numberZ-1361-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSteris Corporation, Mentor, OH, United States
Recall initiated2025-05-23
Classified2026-02-12
Reported by FDA2026-02-18
DistributedNationwide (US)
Quantity10 units
UPC / GTIN / UDI-DI00724995220570
Model numbersMNA-6X0-H

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1361-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.