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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Alcon Research
- Product type
- Ophthalmic Surgical Procedure Packs
- Model numbers
- UDI: *+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X, 17188-04 - Lot # 17PJAY, 19762-03 - Lot # 17PU09, 19203-04- Lot # 17PMWE, 19203-04 - Lot # 17PTXP, 17957-10- Lot #17PTXY
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 24, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
January 7, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The Alcon Custom Pak surgical packs are designed for ophthalmic surgeries, containing various instruments and materials needed for the procedures. Surgeons rely on their sterility to prevent infection during surgeries.
Why This Is Dangerous
Incomplete seals on the packs compromise their sterility, increasing the risk of infections during surgical procedures. This poses a significant health risk to patients undergoing surgery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must act quickly to ensure they do not use compromised surgical packs, which could lead to serious health complications.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recall list: 9903-20, 17188-04, 19762-03, 19203-04, 17957-10.
- Inspect the packaging for any visible damage or incomplete seals.
- Contact your healthcare provider if you are unsure about your product.
Where to find product info
Model numbers can typically be found on the packaging or inside the product's instruction manual.
What timeline to expect
Expect refund processing to take 4-6 weeks after returning the affected packs.
If the manufacturer is unresponsive
- Continue to follow up with Alcon Research via phone or email.
- Consider reporting the issue to the FDA if no response is received.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Ensure that surgical packs are from reputable manufacturers with good safety records.
- Look for visible seals and certifications on packaging.
Documentation advice
Keep records of your purchase, including receipts, and document any communication with Alcon regarding the recall.
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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.
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 Guide
Not sure what to do next? Our guide walks you through the process step by step.
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