Reichert, Inc.: Device Recall

Recall #Z-1501-2025 · 02/28/2025

Class II: Risk

Recall Details

Recall Number
Z-1501-2025
Classification
Class II
Product Type
Device
Recalling Firm
Reichert, Inc.
Status
Ongoing
Date Initiated
02/28/2025
Location
Depew, NY, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1876 units

Reason for Recall

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

Product Description

Phoroptor VRx Digital Refraction System Model Numbers: 16242

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.