The Recall Desk
HighFDA (Devices)·Z-1501-2025·Announced 2025-04-09

Phoroptor VRx Digital Refraction System Recalled for Detachable Head

Reichert is recalling 1,876 units of the Phoroptor VRx Digital Refraction System (Model 16242) due to an assembly defect that could cause the refraction head to detach during eye examinations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm product (optical equipment that could detach during patient use) where no injuries have been reported. The hazard is theoretical, meeting the criterion for score 3.

Plain-English summary

Reichert, Inc. is recalling approximately 1,876 units of the Phoroptor VRx Digital Refraction System (Model 16242). This diagnostic optical instrument is used during eye examinations to measure refractive error and determine eyeglass prescriptions.

The recall is due to an assembly defect that could cause the phoropter head to come loose and potentially detach during use. No injuries or illnesses related to this defect have been reported.

The affected devices include Model 16242 units with UDI-DI 00812559011730. The majority of recalled units are older devices without UDI labels. The devices were distributed nationwide in the United States and internationally to 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.

Eye care professionals and patients should verify whether they have an affected device by checking the Model Number 16242. Those with this device should contact Reichert, Inc. for additional information and guidance.

The recalled product

Product
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Manufacturer
Reichert, Inc.
Category
Medical Device — Diagnostic / Optical Equipment
Hazard
Affected units
1,876

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model Numbers: 16242
  • UDI-DI: 00812559011730
  • Serial Numbers: TBD

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Reichert, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Reichert, Inc.

See all →

Same hazard · assembly defect

See all →