Alcon Research LLC: Device Recall
Recall #Z-1293-2025 · 02/10/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1293-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Alcon Research LLC
- Status
- Ongoing
- Date Initiated
- 02/10/2025
- Location
- Fort Worth, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2511
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.
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
Distribution Pattern
US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.
Other Recalls by Alcon Research LLC
- Class I: Dangerous 11/24/2025
- Class II: Risk 09/30/2025
- Class II: Risk 09/15/2025
- Class II: Risk 08/05/2025
- Class II: Risk 08/05/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.