HIGHFDA DEVICE

HarmonyAIR A-Series Surgical Lighting System

There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

SterisHealth & Personal CareMedical DevicesUDIs: 007249951863880072499518640100724995188320

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
May 15, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
May 15, 2026
Hazard Level
HIGH
Brand
Steris
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Steris
Model numbers
UDIs: 00724995186388, 00724995186401, 00724995188320, 00724995188481, 00724995188467, 00724995188498, 00724995189433, 00724995186562 +12 more
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    May 15, 2026

  2. Reported by FDA DEVICE

    June 24, 2026

  3. RecallRadar source check

    June 30, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Steris Corporation or your healthcare provider for instructions. Notification method: Letter

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Full Description

HarmonyAIR A-Series Surgical Lighting System. Reason: There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.. Classification: Class II. Quantity: 4138 units. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Brand
Model Numbers
UDIs: 00724995186388
00724995186401
00724995188320
00724995188481
00724995188467
+15 more
Affected States
ALL
Report Date
June 24, 2026
Recall Status
ACTIVE

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