The Recall Desk
HighFDA (Devices)·Z-1500-2025·Announced 2025-04-09

Phoroptor VRx Digital Refraction System head may become loose or detach

Reichert, Inc. is recalling 122 units of the Phoroptor VRx Digital Refraction System Model 16241 due to an assembly defect that could cause the device head to become loose and potentially detach.

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 FDA Class II recall involves a structural assembly defect with risk of component detachment, qualifying as a risk-of-harm product. The source contains no reports of injuries or illnesses, keeping the score at 3 per the rubric.

Plain-English summary

Reichert, Inc. is recalling the Phoroptor VRx Digital Refraction System, Model 16241. The recall is due to an assembly defect that could cause the device head to become loose and potentially detach.

The recall affects 122 units 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 the United Kingdom.

The U.S. Food and Drug Administration is overseeing this Class II recall.

The recalled product

Product
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Manufacturer
Reichert, Inc.
Category
Medical Device — Ophthalmic / Refraction
Hazard
Affected units
122

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: (1) 16241
  • UDI-DI: (1) 00812559011716
  • 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.

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Same hazard · loose component

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