# FDA recall Z-0095-2021

> **Alcon Research, LLC** · Class II · device recall initiated 2020-08-24.

## Product

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.

## Reason for recall

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.

## 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.

## Key facts

- **Recall number:** Z-0095-2021
- **Recalling firm:** Alcon Research, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-24
- **Report date:** 2020-10-21
- **Termination date:** 2021-11-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0095-2021

## Citation

> AI Analytics. FDA recall Z-0095-2021. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-0095-2021. Source: US FDA. Licensed CC0.

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