Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Alcon Custom Pak with Non-Latex Symbol Recalled by Alcon Research LLC Due to Customer-designed sterile surgical procedure packs contain latex components...

Date: February 10, 2025
Company: Alcon Research LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research LLC directly.

Affected Products

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

Quantity: 2511

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Alcon Research LLC

Alcon Research LLC has 59 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report