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 Surgical Procedure Pack Recalled by Alcon Research, LLC Due to Due to difficulty removing the liner on the...

Date: October 31, 2022
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 Surgical Procedure Pack

Quantity: 308,610 kits

Why Was This Recalled?

Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.

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 9 total recalls tracked by RecallDetector.

Related Recalls

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