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RecallWatchMedical Device Safety
Class IIOngoingZ-2177-2025

Steris Corporation recalls Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Sy…

Steris CorporationMentor, OH, United StatesReported Aug 6, 2025 · 11 months ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting SystemsUDI
    UDI 00724995203245
    167 affected lots
    04002240280401625167040162517104016251800401625185040162519004020221650402022169
    +159 more040242200304026220070402925148040312205304031220570403125009040322307904032230830403223087040322309104033210660403321070040342306304034230670403423071040342307504034230790403423083040342308704040220030404622011040462201404046220170404622020040462202304048221040405025032040592410004059241030406624134040662413804066241420406722052040672205604067220600406722064040682300504076250220408025008040822212004082221240408222128040822213204089220930408922097040892210104096220080409822014040982201804108220420410822046041082306804109231490410923152041092315504132230570413223060041422317004142231740414223178041422318204142231860414223190041422319404142231980414323003041432300604152230650415223068041522307104152230740415923036041692406904169240740417422053041802309104180230950418023099041802310304180231070418023111041922308204195230100419724177041992400704202230480420223051042022305404202230570420223060042082317004213220410421322045042162320604216232110421623216042162322104216232260421623231042162323604216232410422923010042302305904230233040423023307042302337904230233840423023389042302339404230233990423023451042342204204234220450423422048042392400404242241270424224131042432309604262230040426223008042792203804279220420428824102042892407504289240790428924083042982301904298230230430323199043052319404305231970430722034043112307004323240310432324156043232415904323241620432324165043272206404337240050433724010043372401504340230840434023087043402309004340231110434023116043402312104346220270434622031043462203504347220130434722159043472216304362230680436624179043662418404366241890436624194

What the firm is doing

Steris issued an URGENT MEDICAL DEVICE RECALL NOTICE dated 06/17/2025 to its consignees on 06/23/2025 disseminated via FedEx. The notice explained the issue, potential risk, and requested the following: User Action: Please ensure the following steps are completed: 1. Review the revised Preventive Maintenance Manual and Interval Based Check List language depending on which HarmonyAIR Surgical Lighting System model(s) are in use at your facility (A-Series and/or E-Series) (please reference Attachments B-E of the letter for maintenance instructions). 2. Immediately complete the maintenance activities as instructed, and then again annually going forward. 3. Complete the Medical Device Recall Response Form included with this letter. 4. Return the completed Response Form via email to: Regulatory_Compliance@STERIS.com, or via fax to 440-392-8963. 5. Distributors: If you have further distributed this product, please identify your Customer(s), and notify them of this recall.

DistributionShow details

Worldwide - US Nationwide and Puerto Rico and the country of Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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