FDA Medical devices recall ·
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17… recall
- Recall number
- Z-1293-2025
- Date
- (initiated February 10, 2025)
- Company / brand
- Alcon Research LLC
6201 South Fwy, Fort Worth, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2511
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: H5301ALCON1CPAK10. Pak/Lot(Expiration): 12771-18/JZ5190507(3/31/2025); 18050-10/JZ5200922(5/31/2025), JZ5202199(9/30/2025); 18252-17/JZ5200852(5/31/2025); 12698-09/JZ5201264(6/30/2025); 15632-10, JZ5202447(6/30/2025), JZ5202445(6/30/2025); 3141-45/ JZ5201303(7/31/2025), JZ5201305(7/31/2025); 12630-07/ JZ5201295(8/31/2025); 18925-05/JZ5194816(9/30/2025), JZ5194818(9/30/2025), JZ5196180(9/30/2025), JZ5196182(9/30/2025), JZ5200323(11/30/2025); 19265-05/JZ5201146(9/30/2025), JZ5201148(9/30/2025), JZ5202207(9/30/2025); 13894-16/JZ5201181(9/30/2025), JZ5202143(9/30/2025); 17550-08/JZ5198232(10/31/2025); 12236-18/JZ5201054(11/30/2025); 11854-15/JZ5201561(11/30/2025); 8043-29/JZ5202201(11/30/2025); 12466-17/JZ5205311(12/31/2025), JZ5205313(12/31/2025), JZ5205915(1/31/2026); 15599-17/JZ5205311(12/31/2025), JZ5205313(12/31/2025), JZ5205915(1/31/2026); 14764-09/JZ5197158(2/28/2026); 13194-16/JZ5197142(3/31/2026); 17069-09/JZ5201931(9/30/2026)
Distribution
US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.
States: Alaska Arkansas Arizona Florida Maryland Minnesota North Carolina Nebraska Ohio Pennsylvania Texas Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1293-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.