HIGH

Alcon Laboratories Recalls Custom Pak Surgical Packs Over Sterility Issues

Alcon Laboratories, Inc. recalled 151 units of Custom Pak surgical procedure packs on November 24, 2025. The recall stems from incomplete seals that may affect sterility. Healthcare providers and patients should stop using the products immediately.

Quick Facts at a Glance

Recall Date
November 24, 2025
Hazard Level
HIGH
Brand
Alcon Research
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Ophthalmic procedure packs may have incomplete seals affecting sterility.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Alcon Research LLC or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled models include 9903-20, 17188-04, 19762-03, 19203-04, and 17957-10. These packs were distributed nationwide in California, North Dakota, and Utah. The products are designed for use in various ophthalmic surgeries.

The Hazard

The Custom Pak surgical packs may have incomplete seals, compromising sterility. Using a non-sterile surgical pack can lead to serious infections during procedures.

Reported Incidents

No specific incidents have been reported by the company. The recall is classified as Class I, indicating a high risk of serious injury.

What to Do

Stop using the Custom Pak surgical packs immediately. Follow recall instructions provided in a notification letter from Alcon. Contact Alcon Research LLC or your healthcare provider for further instructions.

Contact Information

For assistance, contact Alcon Research LLC at 1-800-XXX-XXXX or visit their website for more information.

Key Facts

  • Recall date: November 24, 2025
  • Report date: December 31, 2025
  • Quantity recalled: 151 units
  • Affected states: CA, ND, UT

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeOphthalmic Surgical Procedure Packs
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI: *+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X
17188-04 - Lot # 17PJAY
19762-03 - Lot # 17PU09
19203-04- Lot # 17PMWE
19203-04 - Lot # 17PTXP
+1 more
Affected States
ALL
Report Date
December 31, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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