Reichert, Inc. recalls Phoroptor VRx Digital Refraction System Model Numbers: 16241
- Recall date
- February 28, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1500-2025
- FDA classification
- Class II
- Brand / firm
- Reichert, Inc.
- Sold / distributed
- 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.
Why it was recalled
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Phoroptor VRx Digital Refraction System Model Numbers: 16241
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