FDA recall Z-2448-2026

Product

HarmonyAIR A-Series Surgical Lighting System

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2026-05-15

Report date

2026-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2448-2026