HarmonyAIRRecalls & reported problems across all models
Steris Corporation · 240 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one HarmonyAIR model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 86
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 4
We found 240 models of HarmonyAIR by Steris Corporation in the FDA's device registry (GUDID). Together they are named in 86 adverse event reports in the FDA's MAUDE database, received between Mar 24, 2022 and Sep 30, 2026 — classified as 2 injuries, 84 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (60 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
HarmonyAIR recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 15, 2026Open, Classified
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Z-2449-2026 · Root cause: Material/Component Contamination · names 138 of these models · Recall details · FDA record ↗
- May 15, 2026Open, Classified
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Z-2448-2026 · Root cause: Process change control · names 179 of these models · Recall details · FDA record ↗
- Jun 23, 2025Open, Classified
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.
Z-2178-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jun 23, 2025Open, Classified
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.
Z-2177-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported HarmonyAIR problems
Device problems
- Detachment of Device or Device Component60
- Break4
- Flaked3
- Unintended Movement3
- Use of Device Problem3
- Device Handling Problem2
- Insufficient Device Problem Information2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions82
- Pain2
- Head Injury1
- Laceration(s)1
HarmonyAIR models
240 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls6 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls2 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls2 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Suspension SystemTABLE, OPERATING-ROOM, AC-POWERED2 recalls0 reports
- HarmonyAIR A-Series Suspension SystemTABLE, OPERATING-ROOM, AC-POWERED2 recalls0 reports
- HarmonyAIR A-Series Suspension SystemTABLE, OPERATING-ROOM, AC-POWERED2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
- HarmonyAIR A-Series Lighting SystemLight, surgical, ceiling mounted2 recalls0 reports
Recent HarmonyAIR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952317 ↗InjurySep 3, 2026Break; Fracture; Material Fragmentation
The user facility reported that small pieces of plastic of the light handle to their HarmonyAIR A-Series Surgical Lighting System broke off during a procedure and fell into the sterile field. No report of injury. The procedure was delayed while the patient was moved to a different operating room.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588887 ↗InjuryAug 4, 2026Break
The user facility reported that during a patient procedure the light handle cover to their HarmonyAIR A-Series Surgical Lighting System detached from the light handle; the Cover did not enter the sterile field. The procedure was completed successfully. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50128628 ↗MalfunctionJul 10, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785536 ↗MalfunctionJul 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25761046 ↗MalfunctionJun 25, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE LIGHTS TO THEIR HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM WERE TURNING ON AND OFF. USER FACILITY PERSONNEL UTILIZED A MOBILE EXAM LIGHT TO COMPLETE THE PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25626723 ↗MalfunctionJun 18, 2026Mechanical Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED AN INJURY TO THEIR HAND WHILE MOVING THE MONITOR CONNECTED TO THEIR HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM. THE EMPLOYEE SOUGHT MEDICAL TREATMENT HOWEVER, IT IS UNKNOWN THE TYPE OF TREATMENT THAT MAY HAVE BEEN ADMINISTERED.
Patient problems: Pain
MAUDE report 25552947 ↗MalfunctionMay 28, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE AN EMPLOYEE WAS MOVING THE MONITOR CARRIAGE TO THEIR HARMONYAIR MONITOR CARRIER INTO POSITION AND CONTACTED THE LOWER BOOM CAUSING THE MONITOR CARRIAGE COVER TO DETACH. A SHORT PROCEDURE DELAY WAS REPORTED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25318981 ↗MalfunctionMay 21, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS MOVING THE MONITOR CARRIAGE TO THEIR HARMONYAIR MONITOR CARRIER INTO POSITION AND CONTACTED THE LOWER BOOM CAUSING THE MONITOR CARRIAGE COVER TO DETACH AND CONTACT THE EMPLOYEE'S HEAD. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED AND THE EMPLOYEE CONTINUED WORKING. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243226 ↗MalfunctionMay 15, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE DUAL FLAT PANEL MONITOR MOUNT TO THEIR HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM DETACHED FROM THE YOKE-SPRING ARM CONNECTION AND WAS HANGING BY THE WIRES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25187165 ↗MalfunctionMay 7, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT MULTIPLE LIGHTHEADS TO THEIR HARMONYAIR A-SERIES LIGHTING SYSTEMS ARE "CRACKING" SUBSEQUENTLY CAUSING "PIECES" TO FALL ONTO SURGICAL TABLES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116009 ↗MalfunctionMar 18, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THE LIGHT INTENSITY BUTTON FELL OFF THE HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM DURING A PROCEDURE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24632240 ↗MalfunctionMar 6, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR HARMONYAIR NG SILICONE STERILIZABLE COVER DETACHED FROM THE LIGHT HANDLE; THE COVER DID NOT ENTER THE STERILE FIELD. NO REPORT OF PROCEDURE DELAY OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532738 ↗MalfunctionFeb 6, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THE LIGHTHEAD TO THEIR HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM DETACHED FROM THE YOKE-SPRING ARM CONNECTIONS AND WAS HANGING BY THE COMMUTATOR WIRES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281100 ↗MalfunctionFeb 4, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, A SMALL PIECE OF THE LIGHT HANDLE TO THEIR HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM BROKE OFF AND FELL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256611 ↗
Other Steris Corporation products
All Steris Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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