Alcon Custom-Pak — Class II medical device recall Z-0260-2024
Ongoing recall by Alcon Research, LLC, reported 2023-11-15. Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
| Recall number | Z-0260-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LLC, Houston, TX, United States |
| Recall initiated | 2023-09-07 |
| Classified | 2023-11-07 |
| Reported by FDA | 2023-11-15 |
| Quantity | 120 packages |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10380653302278 |
| Lot numbers | 160NMU |
| Model numbers | 14057-09, 45K |
Product
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Reason for recall
Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
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-0260-2024. 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.