The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1293-2025·Announced 2025-03-12

Alcon Custom Pak surgical packs mislabeled as latex-free despite containing latex

Alcon surgical procedure packs contain latex but are labeled as latex-free, creating risk of allergic reaction for patients with latex sensitivity. The company is recalling 2,511 affected units.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This recall involves allergen mislabeling—latex is a common allergen, and the product is incorrectly labeled as latex-free when it contains latex. While the FDA classified this as Class II and no illnesses have been reported, the mislabeling of a common allergen on surgical medical devices creates a risk of harm to patients with latex sensitivity.

Plain-English summary

Alcon Research LLC is recalling Custom Pak sterile surgical procedure packs due to a labeling error. Although the packs contain latex components as designed, the label sealed inside the transparent sterile pouch incorrectly displays a symbol indicating the product is latex-free.

The mislabeling creates a risk of allergic reaction for users or patients with latex sensitivity who may contact the latex components. The recall affects 2,511 units with nationwide distribution across the United States.

Healthcare facilities and affected users should stop using the recalled units immediately. Contact Alcon Research LLC with any questions or to report adverse events.

The recalled product

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
Manufacturer
Alcon Research LLC
Category
Medical Device — Surgical Supplies
Hazard
Affected units
2,511

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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)

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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