Reichert, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1500-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Phoroptor VRx Digital Refraction System Model Numbers: 16241

Product Classification:

Class II

Date Initiated: February 28, 2025

Date Posted: April 9, 2025

Recall Number: Z-1500-2025

Event ID: 96266

Reason for Recall:

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

Status: Ongoing

Product Quantity: 122 units

Code Information:

Model Numbers: (1) 16241; UDI-DI: (1) 00812559011716; 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 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.

Voluntary or Mandated:

Voluntary: Firm initiated