Reported Aug 6, 2025 · Ongoing

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems

Steris Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834

Is this the product you have?

  • Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Lot codes and dates
  • UDI00724995203245:
  • Serial Numbers

    167 of 167 codes

    • 0400224028
    • 0401625167
    • 0401625171
    • 0401625180
    • 0401625185
    • 0401625190
    • 0402022165
    • 0402022169
    • 0402422003
    • 0402622007
    • 0402925148
    • 0403122053
    • 0403122057
    • 0403125009
    • 0403223079
    • 0403223083
    • 0403223087
    • 0403223091
    • 0403321066
    • 0403321070
    • 0403423063
    • 0403423067
    • 0403423071
    • 0403423075
    • 0403423079
    • 0403423083
    • 0403423087
    • 0404022003
    • 0404622011
    • 0404622014
    • 0404622017
    • 0404622020
    • 0404622023
    • 0404822104
    • 0405025032
    • 0405924100
    • 0405924103
    • 0406624134
    • 0406624138
    • 0406624142
    • 0406722052
    • 0406722056
    • 0406722060
    • 0406722064
    • 0406823005
    • 0407625022
    • 0408025008
    • 0408222120
    • 0408222124
    • 0408222128
    • 0408222132
    • 0408922093
    • 0408922097
    • 0408922101
    • 0409622008
    • 0409822014
    • 0409822018
    • 0410822042
    • 0410822046
    • 0410823068
Amount recalled
167 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.