CLASS II ONGOING Device recall · Reported 9 Apr 2025 · FDA Enforcement Report

Phoroptor VRx Digital Refraction System recalled by Reichert

Reichert is recalling Phoroptor VRx Digital Refraction System, distributed nationwide in the US. The recall was initiated on 28 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled122 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1500-2025
FDA event ID: 96266
Recalling firm: Reichert, Depew, NY
Classification: Class II
Status: Ongoing
Recall initiated: 28 Feb 2025
FDA classified: 31 Mar 2025
Reported: 9 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Feb 2025	Recall initiated by company
31 Mar 2025	Classified by FDA	+31 days
9 Apr 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Phoroptor VRx Digital Refraction System Model Numbers: 16241

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96266

Reported	Class	Recall	Company	Reason	Where
9 Apr 2025	CLASS II	Phoroptor VRx Digital Refraction System recalled by Reichert	Reichert	Other	Nationwide

More recalls from Reichert

All 3

Reported	Class	Recall	Company	Reason	Where
9 Apr 2025Device	CLASS II	Phoroptor VRx Digital Refraction System recalled by Reichert	Reichert	Other	Nationwide
6 Sep 2023Device	CLASS II	Phoroptor Vrx Digital Refraction System-Digital refractor recalled	Reichert	Processing Deviation	Nationwide

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