Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Integre Pro Yellow LP561 Recalled by Ellex Medical Pty Ltd. Due to When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ellex Medical Pty Ltd. directly.
Affected Products
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Quantity: 57 systems in total (6 units shipped to United States)
Why Was This Recalled?
When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ellex Medical Pty Ltd.
Ellex Medical Pty Ltd. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report