Use cautionMedical device recall · FDA · Published August 24, 2020
Alcon Custom-Pak Surgical Packs with PROTEXIS Latex Gloves May Have Holes Risking
Alcon Research recalls specific Custom-Pak Surgical Procedure Packs containing PROTEXIS latex micro surgical gloves due to potential holes at cuff folds that could increase infection or cross-patient exposure risk.
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.
Alcon Research is recalling certain Custom-Pak Surgical Procedure Packs that include PROTEXIS latex micro surgical gloves. These gloves may develop holes at the folding area around the cuffs, which could increase the risk of infection or cross-patient exposure to body fluids during surgery. Read more at govinfonow.com/recall/64442-alcon-custom-pak-surgical-packs-with-protexis-latex-gloves-may.
“Alcon Custom-Pak Surgical Packs with PROTEXIS Latex Gloves May Have Holes Risking.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64442-alcon-custom-pak-surgical-packs-with-protexis-latex-gloves-may. Based on FDA recall #Z-0095-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0095-2021%22&limit=1).
The FDA has issued a voluntary Class II recall for Alcon's NVX-10391-04 Systane Eye Gel due to potential lack of sterility assurance, which could lead to eye infections.
How to tell if you have it
Product Name: NVX-10391-04 Systane Eye Gel
Manufacturer: Alcon Research LLC
Recall Class: Class II
Status: Terminated
The hazard
The primary hazard is a lack of assurance of sterility due to FDA inspection observations that may impact product quality, posing a risk of eye infection.
Context
This recall affects approximately 16,971 paks distributed nationwide in the U.S., including states such as 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, and WV. Alcon has a history of sterility-related recalls for ophthalmic products, including recent recalls in 2025 and 2026 for Systane Eye Gel and PRECISION1 Contact Lenses due to incomplete seals or weak seals compromising sterility.
How to tell if you have this one
Check for the specific pack numbers listed in the recall: Pak Number followed by the corresponding lot numbers (e.g., 0433-72 2359088H). The gloves are used by ophthalmic surgeons in eye surgeries.
Brand
Alcon Research
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Pack Number and Lot
Look for the pack number followed by the lot number on the product (e.g., 0433-72 2359088H).
Contact Alcon for Replacement
If you have a recalled pack, contact Alcon Research to get a replacement or refund.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 29 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Nebraska, Nevada, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington, West Virginia.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0095-2021 (August 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0095-2021 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.