FDA Medical devices recall ·
Phoroptor VRx Digital Refraction System Model Numbers: 16242 recall
- Recall number
- Z-1501-2025
- Date
- (initiated February 28, 2025)
- Company / brand
- Reichert, Inc.
3362 Walden Ave, Depew, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1876 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Why was it recalled?
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Numbers: 16242; UDI-DI: 00812559011730; Serial Numbers: TBD; Note: The majority of units within the scope of the planned recall are older devices which do not have a UDI on the label.
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1501-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.