Integre Pro Yellow LP561 — Class II medical device recall Z-1971-2023
Ongoing recall by Ellex Medical Pty Ltd., reported 2023-07-05, distributed nationwide. When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the las
| Recall number | Z-1971-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Ellex Medical Pty Ltd., Mawson Lakes, N/A, Australia |
| Recall initiated | 2023-03-16 |
| Classified | 2023-06-27 |
| Reported by FDA | 2023-07-05 |
| Distributed | Nationwide (US) |
Product
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1971-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.