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

Is Phoroptor VRx Digital Refraction System recalled?

Yes. Reichert recalled Phoroptor VRx Digital Refraction System on 28 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1500-2025.

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

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

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide