HarmonyAIR recallZ-2177-2025 · Steris Corporation · initiated Jun 23, 2025

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company 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: [email protected], 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.

Recall details

Recall number: Z-2177-2025
Status: Open, Classified
Initiated by the company: Jun 23, 2025
Posted by the FDA: Jul 25, 2025
Recalling firm: Steris Corporation
Quantity: 167 units
Product code: FSY
Distribution: Worldwide - US Nationwide and Puerto Rico and the country of Canada.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

HarmonyAIR A-Series Lighting System
Steris Corporation · Light, surgical, ceiling mounted
1 recall0 reports

Product lines

HarmonyAIRSteris Corporation · 240 models · 86 reports · 4 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 97068).

Z-2178-2025 · Open, Classified
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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