Alcon Research LLC recalls Brand Name: Alcon Laboratories
- Recalling company
- Alcon Research LLC
- Product
- Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
- Reason
- Ophthalmic procedure packs may have incomplete seals affecting sterility.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Nov 24, 2025
- Reported
- Dec 31, 2025
- Distribution
- US Nationwide distribution in the states of CA, ND, UT.
- Status
- Ongoing
- Quantity
- 151 units
- Lot / codes
- UDI: *+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X, 17188-04 - Lot # 17PJAY, 19762-03 - Lot # 17PU09, 19203-04- Lot # 17PMWE, 19203-04 - Lot # 17PTXP, 17957-10- Lot #17PTXY
- Company location
- Fort Worth, TX
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0939-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0939-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.