# FDA recall Z-1500-2025

> **Reichert, Inc.** · Class II · device recall initiated 2025-02-28.

## Product

Phoroptor VRx Digital Refraction System Model Numbers: 16241

## Reason for recall

The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

## Distribution

Domestic: Nationwide Distribution.  International: Austria, Bolivia, Canada, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Morocco, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, Slovakia, Switzerland, Thailand, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-1500-2025
- **Recalling firm:** Reichert, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-28
- **Report date:** 2025-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Depew, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1500-2025

## Citation

> AI Analytics. FDA recall Z-1500-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1500-2025. Source: US FDA. Licensed CC0.

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