Alcon Custom Pak (Alcon) – latex component labeling (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Alcon Research LLC
Lot Codes / Batch 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)
Products Sold
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)
Alcon Research LLC is recalling Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141- due to Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 2/10/2025, correction notices were mailed to customers who were asked to do the following: 1) Do not open packaging. Using the provided stickers, adhere one sticker to the outside of affected product near the label to identify it as containing latex. 2) Complete and return the response form electronically via: https://qrco.de/non-latex-symbol Should you have any questions or concerns about this matter, please feel free to call the firm at A 1-800-862-5266
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026