CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report
Alcon Custom Pak with Non-Latex Symbol, Pak recalled by Alcon Research
Alcon Research is recalling Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, distributed nationwide in the US. The recall was initiated on 10 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1293-2025
- FDA event ID
- 96285
- Recalling firm
- Alcon Research, Fort Worth, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Feb 2025
- FDA classified
- 6 Mar 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 10 Feb 2025 | Recall initiated by company | |
| 6 Mar 2025 | Classified by FDA | +24 days |
| 12 Mar 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.
Nationwide AlaskaArkansasArizonaFloridaMarylandMinnesotaNorth CarolinaNebraskaOhioPennsylvaniaTexasWashingtonWisconsin
Questions about this recall
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.
Which lots are affected?
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)
Where was it sold?
US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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