# FDA recall Z-1293-2025

> **Alcon Research LLC** · Class II · device recall initiated 2025-02-10.

## 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.

## Distribution

US Nationwide distribution in  the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.

## Key facts

- **Recall number:** Z-1293-2025
- **Recalling firm:** Alcon Research LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-10
- **Report date:** 2025-03-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Worth, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1293-2025

## Citation

> AI Analytics. FDA recall Z-1293-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1293-2025. Source: US FDA. Licensed CC0.

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