CENTURION FMS — Class II medical device recall Z-1940-2016
Terminated recall by Alcon Research, Ltd., reported 2016-06-15. Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to
| Recall number | Z-1940-2016 |
|---|---|
| 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 | 2016-04-28 |
| Classified | 2016-06-09 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2017-03-31 |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CY, CZ, DE, DK, ES, FI, GB, GR, HK, HR, HU, IE, IN, IT, JP, KR, MA, MX, MY, NL, NO, NZ, PE, PH, PL, PT, RU, SE, SK, TH, TR, TW, UY |
| Quantity | 156,712 units |
| Lot numbers | 1785989H, 1785990H, 1786004H, 1786005H, 1786006H, 1786007H, 1791520H, 1791521H, 1791522H, 1791523H, 1791524H, 1791525H, 1791526H, 1791527H, 1791528H, 1791529H, 1791845H, 1791846H, 1793690H, 1793706H, 1793707H, 1793709H, 1793710H, 1793711H, 1793712H, 1793713H, 1793714H, 1793715H, 1793716H, 1794101H, 1794102H, 1794103H, 1794104H, 1794105H, 1794106H, 1794107H, 1794108H, 1794153H, 1794154H, 1794155H and 218 more |
Product
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Reason for recall
Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.
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-1940-2016. 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.