Depew, NY, United States
Reichert, Inc. recalls
2 recalls recorded since 2018, most recently on 28 February 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 February 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1500-2025, Z-1501-2025
- Phoroptor VRx Digital Refraction System Model Numbers: 16241
- Phoroptor VRx Digital Refraction System Model Numbers: 16242
Ongoing Class II Medical devices
- Recall started
- 20 July 2023
- Reason
- Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2512-2023
- PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additiona
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.