Class II U.S. Food and Drug Administration

Steris Corporation HarmonyAIR A-Series Surgical Lighting System recall: There is a potential for paint delamination (chipping/peeling)

Recall published 4 months ago

There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2448-2026
Published
June 24, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Steris Corporation
Product type
Medical devices
Units affected
4138 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDIs: 00724995186388, 00724995186401, 00724995188320, 00724995188481, 00724995188467, 00724995188498, 00724995189433, 00724995186562, 00724995188696, 00724995188627, 00724995188610, 00724995186074, 00724995186081, 00724995186302, 00724995186319, 00724995188269, 00724995186371, 00724995188634, 00724995186326, 00724995186067, 00724995186548, 00724995186579, 00724995188580, 00724995187149, 00724995187170, 00724995187989, 00724995187644, 00724995188337, 00724995189297, 00724995188313, 00724995186128, 00724995188689, 00724995188252, 00724995188474, 00724995188597, 00724995188221, 00724995189174, 00724995188276, 00724995186180, 00724995189143 00724995186111, 00724995186340, 00724995187224, 00724995189075, 00724995188306 00724995188603, 00724995189051, 00724995200954, 00724995200022, 00724995199906 00724995190033, 00724995186678, 00724995188351, 00724995188665, 00724995187996 00724995189068, 00724995189099, 00724995189150, 00724995199869, 00724995187385 00724995187347, 00724995200886, 00724995190361, 00724995200893, 00724995200916 00724995186333, 00724995187026, 00724995187262, 00724995186715, 00724995186746 00724995188283, 00724995187279, 00724995186135, 00724995188511, 00724995188009, 00724995188245, 00724995189310, 00724995186555, 00724995188504, 00724995187033 00724995190354, 00724995188238, 00724995186739, 00724995188290, 00724995199890, 00724995187156, 00724995187187, 00724995187521, 00724995187552, 00724995186142, 00724995186647, 00724995185985, 00724995186104, 00724995187781, 00724995189334 00724995185954, 00724995186418, 00724995187217, 00724995189181, 00724995187415 00724995188030, 00724995189372, 00724995201128, 00724995189990, 00724995189235 00724995189204, 00724995200251, 00724995201135, 00724995200367, 00724995200343 00724995200114, 00724995200909, 00724995186357, 00724995188542, 00724995186173 00724995186661, 00724995200732, 00724995186807, 00724995200701, 00724995187569, 00724995186364, 00724995199401, 00724995186203, 00724995189198, 00724995190040 00724995186098, 00724995189136, 00724995189105, 00724995200329, 00724995188412, 00724995185978, 00724995186784, 00724995187712, 00724995188047, 00724995187088 00724995186685, 00724995186692, 00724995188641, 00724995186920, 00724995188658 00724995199388, 00724995200138, 00724995186500, 00724995199876, 00724995199364 00724995188672, 00724995188535, 00724995188122, 00724995186425, 00724995186616 00724995188375, 00724995187798, 00724995185947, 00724995186487, 00724995188016 00724995186753, 00724995188726, 00724995186166, 00724995199371, 00724995186906, 00724995188399, 00724995186449, 00724995189167, 00724995187231, 00724995187200 00724995187460, 00724995200770, 00724995200084, 00724995187576, 00724995187606 00724995200466, 00724995188108, 00724995186395, 00724995188054, 00724995189211 00724995200480, 00724995200947, 00724995189228, 00724995187620, 00724995189419 00724995201074, 00724995187125, 00724995188344, 00724995186623, 00724995188849 00724995200930, 00724995188078, 00724995188948, 00724995187286, 00724995187453 00724995199944, 00724995199913, 00724995186432, 00724995187484, 00724995187538 00724995190002, 00724995187248, 00724995188702, 00724995187378, 00724995185961 00724995186593, 00724995200961, 00724995189280, 00724995186722, 00724995186760 00724995187729, and 00724995187583; Serial Numbers: 0400224025 0402925005 0405124082 0407625017 0410525114 0413525005 0416725078 0419625227 0421623131 0423023296 0424625031 0426724199 0428824307 0431124255 0433724085 0400324053 0402925009 0405124092 0407625022 0410525120 0413525006 0416725082 0419625232 0421623135 0423023301 0424625032 0426824004 0428824308 0431225037 0433724089 0400324060 0402925023 0405124097 0407625025 0410525124 0413525008 0416725086 0419625237 0421623139 0423023332 0424625033 0426824008 0428923045 0431225041 0433724093 0400324064 0402925028 0405124102 0407625028 0410525128 0413525009 0416725091 0419625260 0421623143 0423023336 0424625034 0426825108 0428924044 0431225045 0433724097 0400324068 0402925033 0405124…
UPC codes
00724995186388, 00724995186401, 00724995188320, 00724995188481, 00724995188467, 00724995188498, 00724995189433, 00724995186562, 00724995188696, 00724995188627, 00724995188610, 00724995186074, 00724995186081, 00724995186302, 00724995186319, 00724995188269, 00724995186371, 00724995188634, 00724995186326, 00724995186067

Products covered by this recall

HarmonyAIR A-Series Surgical Lighting System

Check your product

The notice names 21 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00724995186388
  • 00724995186401
  • 00724995188320
  • 00724995188481
  • 00724995188467
  • 00724995188498
  • 00724995189433
  • 00724995186562
  • 00724995188696
  • 00724995188627
  • 00724995188610
  • 00724995186074
  • 00724995186081
  • 00724995186302
  • 00724995186319
  • 00724995188269
  • 00724995186371
  • 00724995188634
  • 00724995186326
  • 00724995186067

Serial number

On the rating plate, often next to the date of manufacture.

  • 0400224025 0402925005 0405124082 04076250

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Steris Corporation — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Steris Corporation — 5960 Heisley Rd, Mentor, OH, 44060-1834

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Steris Corporation medical devices recalled?

There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00724995186388, 00724995186401, 00724995188320. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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