HIGHFDA DEVICE

HarmonyAIR A-Series Surgical Lighting System

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

SterisHealth & Personal CareMedical DevicesUDIs: 007249951859470072499518641800724995187156

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: 00724995185947, 00724995186418, 00724995187156, 00724995188009, 00724995188498, 00724995189198, 00724995185954, 00724995186425 +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

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

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: The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.. Classification: Class II. Quantity: 2101 units. Distribution: Worldwide - US Nationwide distribution.

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: 00724995185947
00724995186418
00724995187156
00724995188009
00724995188498
+15 more
Affected States
ALL
Report Date
June 24, 2026
Recall Status
ACTIVE

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