Alcon Custom Pak Surgical Procedure Pack
Medical device recall Z-0354-2023. Published in FDA’s Enforcement Report on Dec 7, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 7, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 49 states named
- 308,610 kits how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alcon Custom Pak Surgical Procedure Pack
308,610 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI Codes for: UDI for Latex Free Custom Pak: H5301ALCON1CPAK10B UDI for Latex Free Custom Pak: H5302ALCON2CPAK20E Custom Pak # / Lot #: Custom Pak # Lot # 100007214 14ACYR 100007214 14C8KP 100007214 14CFP3 100011843 149HV5 100011843…
Every code shown here, 1,999 characters
UDI Codes for: UDI for Latex Free Custom Pak: H5301ALCON1CPAK10B UDI for Latex Free Custom Pak: H5302ALCON2CPAK20E Custom Pak # / Lot #: Custom Pak # Lot # 100007214 14ACYR 100007214 14C8KP 100007214 14CFP3 100011843 149HV5 100011843 150DMH 100012716 150CX9 100060730 2538660H 100060730 2540367H 100060730 14UWK4 100060730 14XTYA 100060730 14YHL2 100060730 150LWW 100064778 14DEM2 100064778 14FY9L 100064778 14NFK2 100064778 14TX0N 100064778 14TX0V 100064778 JZ5141146 100064778 14X73C 100072572 149WDA 100072572 149YF1 100072572 14C6LE 100082908 JZ5120745 100082908 JZ5121811 100082908 JZ5123118 100082908 JZ5123538 100082908 JZ5125017 100082908 JZ5126725 100082908 JZ5141666 100083383 JZ5125990 100083383 JZ5125085 100083383 JZ5128291 100083383 JZ5128981 100083383 JZ5137217 100083383 JZ5141156 100083383 JZ5145948 100087432 14WRAH 100104358 JZ5085044 100104358 JZ5094040 100104358 JZ5093549 100104358 JZ5096554 100104358 JZ5105416 100104358 JZ5112098 100104358 JZ5122222 100104358 JZ5123117 100104358 JZ5123496 100104358 JZ5120791 100104358 JZ5124955 100104358 JZ5125749 100104358 JZ5126648 100104358 JZ5127232 100104358 JZ5144645 100104358 JZ5147589 100105558 JZ5120612 100105558 JZ5125992 100105558 JZ5122518 100105558 JZ5125087 100105558 JZ5123597 100105558 JZ5126803 100105558 JZ5128293 100105558 JZ5128983 100105558 JZ5142177 100105833 14FY7H 100105833 14FY8N 100105833 14H1YR 100107426 JZ5121018 100107426 JZ5121016 100107426 JZ5121014 100107426 JZ5129268 100107426 JZ5129270 100107426 JZ5129719 100107426 JZ5129717 100107426 JZ5132352 100107426 JZ5132356 100107426 JZ5132354 100107426 JZ5133155 100107426 JZ5134657 100107426 JZ5134189 100107426 JZ5138061 100107426 JZ5138300 100107426 JZ5141486 100107426 JZ5142286 100107426 JZ5143437 100107426 JZ5143439 100107426 JZ5144848 100108230 14C8KH 100108230 14CKE0 100108230 14CP9T 100108230 14CRRF 100108230 14UW2L 100112025 14KWY0 100112025 14NL63 100112025 14UFK9 100112025 14X72X 100112025 1506D3 100112062 14AU9M 100112062 14AY9X 100112062…
FDA’s list runs to 114,187 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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, WI, WV, and WY; and O.U.S. (foreign) to countries of: Australia, Canada, France, Germany, Italy, Mexico, New Zealand, Portugal and United Kingdom.
The states and territories these words name
49 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 31, 2022.
- FDA classified it on Dec 1, 2022.
- FDA’s Enforcement Report published it on Dec 7, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Alcon Research, LLC, of Houston, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 114,187 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.