Alcon Custom Pak Surgical Procedure Packs: Difficulty Removing Liner May Cause Product
Alcon recalls certain Custom Pak Surgical Procedure Packs due to difficulty removing adhesive liners, which may render the product unusable. The manufacturer has also observed an increase in adhesive-related skin injuries with these affected lots.
Lower-risk recall
Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.
Contact the company
What happened, in plain English
Alcon is recalling specific Custom Pak Surgical Procedure Packs because the adhesive liners are difficult to remove, potentially making the products unusable. The manufacturer has also reported more adhesive-related skin injuries with these affected lots. Read more at govinfonow.com/recall/59794-alcon-custom-pak-surgical-procedure-packs-difficulty-removing-liner-may.
Source Summary by GovInfoNow · govinfonow.com/recall/59794-alcon-custom-pak-surgical-procedure-packs-difficulty-removing-liner-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0354-2023
Cite this page
“Alcon Custom Pak Surgical Procedure Packs: Difficulty Removing Liner May Cause Product.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59794-alcon-custom-pak-surgical-procedure-packs-difficulty-removing-liner-may. Based on FDA recall #Z-0354-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0354-2023%22&limit=1).
Why it’s dangerous
The adhesive components of the affected drapes have difficulty being removed, which can make the product unusable. Additionally, the manufacturer has observed an increase in adhesive-related skin injuries with these specific lots.
Who’s affected
Healthcare professionals using these surgical procedure packs for procedures are most at risk. The affected lots are identified by specific UDI codes and lot numbers listed in the recall.
How to tell if you have this one
Check your Custom Pak Surgical Procedure Pack for the UDI codes listed in the recall: H5301ALCON1CPAK10B, H5302ALCON2CPAK20E, and the specific lot numbers provided in the recall.
- Brand
Alcon- Category
Medical device
What to do — step by step
Check your product
Look for the UDI codes and lot numbers listed in the recall to determine if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 49 states.
FDA distribution: “Worldwide Distribution: U.S.(nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,…” 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, 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 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 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0354-2023 (October 31, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0354-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.