Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health” PROTEXIS” Latex Micro Surgical Gloves -…
Medical device recall Z-0095-2021. Published in FDA’s Enforcement Report on Oct 21, 2020.
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 Oct 21, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 29 states named
- 16,971 Paks 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?
The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health” PROTEXIS” Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
16,971 Paks, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Pak Number followed by the corresponding lot numbers are as follows: 0433-72 2359088H 0433-72 2362546H 10008-15 2364745H 10391-04 2383902H 10391-04 2388582H 10391-04 2397523H 10477-17 2346459H 10477-18 2383904H 1087-63 2353407H 1087-64…
Every code shown here, 1,995 characters
Pak Number followed by the corresponding lot numbers are as follows: 0433-72 2359088H 0433-72 2362546H 10008-15 2364745H 10391-04 2383902H 10391-04 2388582H 10391-04 2397523H 10477-17 2346459H 10477-18 2383904H 1087-63 2353407H 1087-64 2395495H 11016-11 2350017H 11311-07 2403959H 11311-07 2406031H 11345-08 2363773H 11345-08 2363774H 11345-08 2363775H 11437-03 2362137H 11437-03 2379506H 11437-03 2385658H 11437-03 2394132H 11458-17 2370067H 11458-17 2375171H 11458-17 2390120H 11458-17 2393525H 11458-17 2400520H 11786-01 2347153H 11786-01 2380332H 1179-43 2379382H 1179-43 2384124H 1179-43 2384125H 1179-43 2388444H 1179-43 2388445H 11876-18 2362142H 11876-18 2369176H 11876-18 2379510H 1231-57 2365132H 1231-57 2369489H 1231-57 2372302H 1231-57 2383379H 1231-57 2391174H 1231-57 2393089H 1231-57 2399904H 1231-57 2401798H 1231-57 2403559H 12732-05 2394138H 12736-09 2365968H 12736-09 2375271H 12736-09 2390575H 12736-09 2392097H 12736-09 2395160H 12878-13 2384211H 12878-13 2385672H 12896-09 2358037H 12896-09 2376070H 12896-09 2385542H 12896-09 2387051H 12896-09 2394141H 12896-09 2395582H 13152-08 2384214H 13193-11 2372672H 13193-11 2394902H 13194-12 2346890H 13194-13 2363370H 13194-13 2369833H 13194-13 2377937H 13194-13 2390027H 13194-13 2391920H 13194-13 2392322H 13194-13 2396531H 13194-13 2400270H 13194-13 2402421H 13235-16 2324761H 13391-09 2315328H 13391-09 2343461H 13391-09 2350133H 13391-09 2357090H 13391-10 2370048H 13391-10 2378299H 13391-10 2380086H 13391-10 2390108H 13391-10 2393512H 13391-10 2396778H 13391-10 2399535H 13477-10 2357278H 13477-10 2361677H 13477-10 2363897H 13477-10 2365971H 13477-10 2370199H 13477-10 2375273H 13477-10 2380877H 13477-10 2390175H 13477-10 2392100H 13477-10 2394534H 13667-08 2346266H 13667-09 2361271H 13667-09 2365630H 13667-09 2378038H 13667-09 2383643H 13667-09 2396582H 13667-09 2400368H 13698-13 2384221H 13698-13 2387057H 13698-13 2394149H 13699-16 2362174H 13699-16 2389133H 13699-16 2392378H 13699-16 2399300H 13700-16 2366535H…
FDA’s list runs to 14,684 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.
U.S. Nationwide distribution including in the states of AK, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MN, MO, NE, NJ, NV, NY, OK, PA, TN, TX, UT, WA, WV.
The states and territories these words name
29 states and territories.
Every one of them
- Alaska
- Arkansas
- Arizona
- California
- Colorado
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Maryland
- Minnesota
- Missouri
- Nebraska
- New Jersey
- Nevada
- New York
- Oklahoma
- Pennsylvania
- Tennessee
- Texas
- Utah
- Washington
- West Virginia
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Aug 24, 2020.
- FDA classified it on Oct 9, 2020.
- FDA’s Enforcement Report published it on Oct 21, 2020.
- FDA terminated it on Nov 17, 2021.
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 14,684 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
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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.