FDA DevicesClass II

ALYON Surgical Lighting System

Publicado: 24 de junio de 2026ID de Retiro: Z-2450-2026Categoría: Dispositivos MédicosPaís: Estados Unidos
US
Medical DeviceFDA DevicesUSUS

ALYON Surgical Lighting System

Recalling Firm: Steris Corporation

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Motivo del Retiro / Peligro

The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

Descripción del Producto e Identificación

ALYON Surgical Lighting System

Additional Source Details

FieldValue
CityMentor
StateOH
Event id98768
Address 15960 Heisley Rd
Code infoUDIs: 00724995223182 00724995223137, 00724995223151, 00724995223175, 00724995222895, 00724995222994 00724995223014, 00724995223021, 00724995223083, 00724995223106, 00724995222758 00724995223120, 00724995223113, 00724995222840, 00724995223038, 00724995223076 00724995222987, 00724995223007, 00724995222703, 00724995222727, 00724995223090 00724995225711, 00724995225681, 00724995225698, 00724995225728, 00724995222826 00724995222802, 00724995222857, 00724995222697, 00724995222956, and 00724995223229
Postal code44060-1834
Report date20260624
Product typeDevices
Product quantity549 units
Reason for recallThe the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260515
Initial firm notificationLetter
Center classification date20260615

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 ALYON Surgical Lighting System?

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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Resumen

  • Empresa ResponsableSteris Corporation
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionWorldwide - US Nationwide distribution.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: Steris Corporation - ALYON Surgical Lighting System

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https://therecallfile.com/es/recalls/alyon-surgical-lighting-system/FDA-Z-2450-2026
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