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Use caution Medical device recall · FDA · Published June 23, 2025

Steris Dual Flat Panel Monitor Accessories Recall: Yoke Assembly May Detach

Steris recalls Dual Flat Panel Monitor accessories for HarmonyAIR E-Series surgical lighting systems due to potential yoke assembly detachment. Affected units have specific serial numbers.

🇺🇸 FDA recall #Z-2178-2025Medical deviceSteris ›
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Recalling firmSteris Corporation5960 Heisley Rd · Mentor, OH 44060-1834
✎ GovInfoNow plain-language explainer

Steris is recalling certain Dual Flat Panel Monitor accessories for HarmonyAIR E-Series surgical lighting systems because the yoke assembly might detach from the spring arm. This could cause the yoke to hang from the wiring, potentially leading to interference with surgical procedures. Read more at govinfonow.com/recall/51978-steris-dual-flat-panel-monitor-accessories-recall-yoke-assembly-may.

Source Summary by GovInfoNow · govinfonow.com/recall/51978-steris-dual-flat-panel-monitor-accessories-recall-yoke-assembly-may · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2178-2025

Cite this page

“Steris Dual Flat Panel Monitor Accessories Recall: Yoke Assembly May Detach.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51978-steris-dual-flat-panel-monitor-accessories-recall-yoke-assembly-may. Based on FDA recall #Z-2178-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2178-2025%22&limit=1).

The FDA announced on June 23, 2025, that Steris Corporation is recalling Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems because the yoke assembly may detach from the spring arm. The agency recalled 59 units distributed worldwide, including in the U.S., Puerto Rico, and Canada.

How to tell if you have it

  • Brand: Steris
  • Product: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
  • UDI: 00724995171155
  • Serial numbers: 0416920048, 0417820084, 0417820088, 0417820096, 0417820110, 0417820092, 0417820100, 0418420047, 0419620004, 0419520013, 0428620109, 0428620112, 0430020191, 0431720044, 0435120043, 0435120047, 0435120051, 0401321042, 0413221047, 0413221199, 0413721008, 0413721012, 0417221023, 0417221027, 0417221031, 0420021018, 0420021022, 0420021026, 0420721021, 0429720003, 0420921073, 0426321186, 0426321190, 0427121121, 0427121125, 0427321012, 0427321002, 0427321005, 0413921017, 0434121095, 0434121098, 0434121101, 0434121104, 0434121107, 0434121110, 0434121113, 0400722081, 0406022021, 0406022025, 0406022034, 0406022038, 0406022017, 0406022014, 0406022011, 0417122078, 0417122081, 0417122084, 0417122087, 0417122090
  • Quantity: 59 units

The hazard

According to the FDA, the DFPM yoke assembly may detach from the spring arm. The agency stated that should the yoke assembly detach, it would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

Context

GovInfoNow's records show Steris Corporation has 29 other recalls on record since June 15, 2017. Other recent recalls of similar products include Steris HarmonyAIR A-Series Surgical Lights (May 15, 2026), Steris - Steris Corporation (May 15, 2026), and Steris AMSCO 7053HP Washer/Disinfector Recall (Nov. 19, 2025). Other recent recalls of similar products include Olympus HX-400U-30 Ligating Device Recall (Oct. 30, 2025) and Philips Azurion System Recall (March 31, 2026).

How to tell if you have this one

Check if your HarmonyAIR E-Series surgical lighting system has a Dual Flat Panel Monitor accessory with the listed serial numbers. The recall includes specific units identified by their unique serial numbers.

  • Brand
    Steris
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide and Puerto Rico and the country of Canada.
Recall numberProduct, codes & lotsQuantity
Z-2177-2025Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems; UDI: 00724995203245: Serial Numbers: 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, 0410923149, 0410923152, 0410923155, 0413223057, 0413223060, 0414223170, 0414223174, 0414223178, 0414223182, 0414223186, 0414223190, 0414223194, 0414223198, 0414323003, 0414323006, 0415223065, 0415223068, 0415223071, 0415223074, 0415923036, 0416924069, 0416924074, 0417422053, 0418023091, 0418023095, 0418023099, 0418023103, 0418023107, 0418023111, 0419223082, 0419523010, 0419724177, 0419924007, 0420223048, 0420223051, 0420223054, 0420223057, 0420223060, 0420823170, 0421322041, 0421322045, 0421623206, 0421623211, 0421623216, 0421623221, 0421623226, 0421623231, 0421623236, 0421623241, 0422923010, 0423023059, 0423023304, 0423023307, 0423023379, 0423023384, 0423023389, 0423023394, 0423023399, 0423023451, 0423422042, 0423422045, 0423422048, 0423924004, 0424224127, 0424224131, 0424323096, 0426223004, 0426223008, 0427922038, 0427922042, 0428824102, 0428924075, 0428924079, 0428924083, 0429823019, 0429823023, 0430323199, 0430523194, 0430523197, 0430722034, 0431123070, 0432324031, 0432324156, 0432324159, 0432324162, 0432324165, 0432722064, 0433724005, 0433724010, 0433724015, 0434023084, 0434023087, 0434023090, 0434023111, 0434023116, 0434023121, 0434622027, 0434622031, 0434622035, 0434722013, 0434722159, 0434722163, 0436223068, 0436624179, 0436624184, 0436624189, 0436624194;167 units
Z-2178-2025Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems; UDI: 00724995171155: Serial numbers: 0416920048, 0417820084, 0417820088, 0417820096, 0417820110, 0417820092, 0417820100, 0418420047, 0419620004, 0419520013, 0428620109, 0428620112, 0430020191, 0431720044, 0435120043, 0435120047, 0435120051, 0401321042, 0413221047, 0413221199, 0413721008, 0413721012, 0417221023, 0417221027, 0417221031, 0420021018, 0420021022, 0420021026, 0420721021, 0429720003, 0420921073, 0426321186, 0426321190, 0427121121, 0427121125, 0427321012, 0427321002, 0427321005, 0413921017, 0434121095, 0434121098, 0434121101, 0434121104, 0434121107, 0434121110, 0434121113, 0400722081, 0406022021, 0406022025, 0406022034, 0406022038, 0406022017, 0406022014, 0406022011, 0417122078, 0417122081, 0417122084, 0417122087, 0417122090.59 units
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Identify if your accessory has one of the listed serial numbers: 0416920048, 0417820084, 0417820088, and other specific numbers.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Worldwide - US Nationwide and Puerto Rico and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Jun 23, 202512. FDA classified it Class II: Jul 25, 202523. Published in FDA’s Enforcement Report: Aug 6, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2178-2025 (June 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2178-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA