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FDA DevicesClass II

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

Veröffentlicht: 18. Februar 2026Rückruf-ID: Z-1361-2026Kategorie: MedizinprodukteLand: Vereinigte Staaten
US
Medical DeviceFDA DevicesUSUS

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

Recalling Firm: Steris Corporation

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Mitteilung übersetzenTranslate notice text, hazard warnings, and descriptions into any supported language.

Grund für den Rückruf / Gefahr

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.

Produktbeschreibung & Identifikation

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

Additional Source Details

FieldValue
CityMentor
StateOH
Event id98266
Address 15960 Heisley Rd
Address 2N/A
Code infoUDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829
Postal code44060-1834
Report date20260218
Product typeDevices
Product quantity10 units
Reason for recallThis 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20250523
Initial firm notificationLetter
Center classification date20260212

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Übersicht

  • Rückrufendes UnternehmenSteris Corporation
  • StatusOngoing
  • RisikostufeClass II
  • DistributionUS Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
Recall Hazard Severity
High Alert (Class I)
Offizielle Behördenwarnung

📢 Warnung teilen

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🚨 SAFETY ALERT: Steris Corporation - Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

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https://therecallfile.com/de/recalls/barco-mna-with-the-hexavue-ip-integration-system-model-catalog-number/FDA-Z-1361-2026
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