FDA-Device2025-04-09Class II

Phoroptor VRx Digital Refraction System Model Numbers: 16241

Reichert, Inc.
Hazard

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

Sold states
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.
Affected count
122 units
Manufactured in
3362 Walden Ave, Depew, NY, United States
Products
Phoroptor VRx Digital Refraction System Model Numbers: 16241

Official notice

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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief