Alcon Custom Pak with Non-Latex Symbol — Class II medical device recall Z-1293-2025
Ongoing recall by Alcon Research LLC, reported 2025-03-12, distributed nationwide. Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content lab
| Recall number | Z-1293-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research LLC, Fort Worth, TX, United States |
| Recall initiated | 2025-02-10 |
| Classified | 2025-03-06 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,511 |
| Reason classes | labeling, sterility |
| Lot numbers | 12630-07, 15632-10, 3141-45 |
Product
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
Reason for recall
Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.
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-1293-2025. 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.