# FDA recall Z-0939-2026

> **Alcon Research LLC** · Class I · device recall initiated 2025-11-24.

## Product

Brand Name: Alcon Laboratories, Inc.  Product Name: Custom Pak  Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10    Software Version: N/A  Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure.  Component: N/A

## Reason for recall

Ophthalmic procedure packs may have incomplete seals affecting sterility.

## Distribution

US Nationwide distribution in the states of CA, ND, UT.

## Key facts

- **Recall number:** Z-0939-2026
- **Recalling firm:** Alcon Research LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-24
- **Report date:** 2025-12-31

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0939-2026

## Citation

> AI Analytics. FDA recall Z-0939-2026. Retrieved 2026-08-22 from https://api.ai-analytics.org/recall/Z-0939-2026. Source: US FDA. Licensed CC0.

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