Ellex Medical Fixed eye Safety filters Model Integre S LP5532 — Class II medical device recall Z-1270-2016
Terminated recall by Laserex Systems Inc., reported 2016-04-13. The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the s
| Recall number | Z-1270-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Laserex Systems Inc., EDEN PRAIRIE, MN, United States |
| Recall initiated | 2016-02-01 |
| Classified | 2016-04-07 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2016-10-27 |
| Model numbers | 3143270 |
Product
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
Reason for recall
The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
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-1270-2016. 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.