# FDA recall Z-2163-2025

> **Johnson & Johnson Vision Care, Inc.** · Class II · device recall initiated 2025-06-12.

## Product

ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL

## Reason for recall

Due to defects (bubbles/voids) identified during standard finished goods testing

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC TN, TX, UT, VA, WA, WI, and WY. The countries of Belgium, Bermuda, Canada, Switzerland, Denmark, Germany, Spain, France, United Kingdom, Italy, Netherlands, Poland, Sweden, Singapore, and South Korea.

## Key facts

- **Recall number:** Z-2163-2025
- **Recalling firm:** Johnson & Johnson Vision Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-12
- **Report date:** 2025-07-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jacksonville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2163-2025

## Citation

> AI Analytics. FDA recall Z-2163-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2163-2025. Source: US FDA. Licensed CC0.

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