UnratedMedical device recall · FDA · Published September 15, 2025
Alcon Constellation Ultravit 10K and Hypervit 20K Recall: Product Hazard
Alcon Research LLC recalls Constellation Ultravit 10K and Constellation Hypervit 20K products due to unspecified hazard. Check your product's serial number against the list to see if it's affected.
📍Recalling firmAlcon Research LLC6201 South Fwy · Fort Worth, TX 76134-2099
✎ GovInfoNow plain-language explainer
Alcon Research LLC is recalling Constellation Ultravit 10K and Constellation Hypervit 20K products because of a potential hazard. Affected products have specific serial numbers listed in the recall notice. Consumers should check their product against the provided list to determine if they are affected. Read more at govinfonow.com/recall/51292-alcon-constellation-ultravit-10k-and-hypervit-20k-recall-product-hazard.
“Alcon Constellation Ultravit 10K and Hypervit 20K Recall: Product Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51292-alcon-constellation-ultravit-10k-and-hypervit-20k-recall-product-hazard. Based on FDA recall #Z-0581-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0581-2026%22&limit=1).
The FDA has issued a voluntary recall for 28,323 units of Alcon ophthalmic products due to potential sterility risks.
How to tell if you have it
5414660543879/C25910-07
H5301ALCON1CPAK10/19853-02
The hazard
Incomplete seals may cause contamination, leading to a lack of sterility assurance.
Context
Alcon Research LLC has 24 other recalls on record since July 25, 2018. Recent similar recalls include the April 21, 2026 Systane Eye Gel recall for lack of sterility assurance and the September 30, 2025 PRECISION1 Contact Lens recall due to potential weak seals.
How to tell if you have this one
Check your product's serial number against the list of numbers provided in the recall notice. The products are labeled as Constellation Ultravit 10K and Constellation Hypervit 20K with specific serial numbers.
Brand
Alcon Research
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Serial Number
Compare your product's serial number with the list of numbers provided in the recall notice to see if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution including in the states of PA, MN, CA, FL, LA, CO, KS, IL, AK, OH, NY, NM, DE, TX, GA, NJ, MI, SC, AR, IN, OR, VA, WI, AZ, TN, KY, AL, MA, WA, NE, MT, SD, CT, NC, MO, UT, WY, DC, NH, MD, ID, RI, ND,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0581-2026 (September 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0581-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.