INFINITI Ultrasound Pack — Class II medical device recall Z-1597-2016
Terminated recall by Alcon Research, Ltd., reported 2016-05-11, distributed nationwide. The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigatio
| Recall number | Z-1597-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2014-10-06 |
| Classified | 2016-05-03 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2017-03-31 |
| Distributed | Nationwide (US) |
| Quantity | 6,597 packages |
| Reason classes | packaging |
| Lot numbers | 1623138H, 1623139H, 1623140H, 1623141H, 1623142H, 1623148H, 1623765H, 1623766H, 1623767H, 1623768H |
| Model numbers | 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723 |
Product
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
Reason for recall
The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.
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-1597-2016. 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.