HarmonyAIR A-Series Surgical Lighting System

FDA device recall Z-2448-2026 · posted 2026-06-15 · Open, Classified

Recall details

Recalling firm

Steris Corporation

Reason for recall

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

Action taken

An URGENT MEDICAL DEVICE RECALL notification letter dated 5/1/26 was sent to customers. STERIS Action All affected Customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their lighting system(s) to perform the correction as soon as possible. For the paint issue, each affected lighting system will undergo a full visual inspection for any signs of paint delamination; as needed a service kit will be installed to prevent paint chipping from occurring or if deemed necessary replaced. For the button issue, each affected lighting system will undergo inspection for any signs of potential separation from the light head and handle. Buttons failing this inspection will be replaced. User Action Users can continue to use their lighting system(s) prior to completion of the correction. Users are reminded to ensure no excess fluids remain on light head during or after cleaning, per the Operator Manuals. Should any issues be observed prior to the correction being completed, users should submit a complaint by contacting STERIS Customer Service at 1-800-548-4873. Users are also reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact your local Account Manager.

Root cause

Process change control

Status

Open, Classified

Product code

FSY

Quantity affected

4138 units

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.

Date initiated

2026-05-15

Date posted

2026-06-15

Location

Mentor, OH