Reported Mar 12, 2025 · Ongoing

Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07,…

Alcon Research LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alcon Research LLC · 6201 South Fwy · Fort Worth, TX · 76134-2099

Is this the product you have?

  • 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
Lot codes and dates

18 of 18 products · 31 lot codes

Recalled lot codes, grouped by product number
PakLot (Expiration)
12771-18
  • JZ51905073/31/2025
18050-10
  • JZ52009225/31/2025
  • JZ52021999/30/2025
18252-17
  • JZ52008525/31/2025
12698-09
  • JZ52012646/30/2025
3141-45
  • JZ52013037/31/2025
  • JZ52013057/31/2025
12630-07
  • JZ52012958/31/2025
18925-05
  • JZ51948169/30/2025
  • JZ51948189/30/2025
  • JZ51961809/30/2025
  • JZ51961829/30/2025
  • JZ520032311/30/2025
19265-05
  • JZ52011469/30/2025
  • JZ52011489/30/2025
  • JZ52022079/30/2025
13894-16
  • JZ52011819/30/2025
  • JZ52021439/30/2025
17550-08
  • JZ519823210/31/2025
Amount recalled
2511

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:41 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.