Recall Z-1293-2025— Alcon Research LLC

Name: FDA recall Z-1293-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-10

Class II · Ongoing

Class II FDA medical device recall by Alcon Research LLC, initiated 2025-02-10. It names one FDA 510(k) clearance: K880961. 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: 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..

Recalling firm: Alcon Research LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-02-10
Firm location: Fort Worth, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K880961 — ALCON SURGICAL PROCEDURE PACKSAlcon Laboratories·cleared 1988-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.