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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96266

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 28, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Reichert, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Phoroptor VRx Digital Refraction System Model Numbers: 16241

Z-1500-2025
Recall number
Z-1500-2025
Initiated
February 28, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Reichert, Inc.
Quantity
122 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.

device · product 2 of 2

Phoroptor VRx Digital Refraction System Model Numbers: 16242

Z-1501-2025
Recall number
Z-1501-2025
Initiated
February 28, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Reichert, Inc.
Quantity
1876 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Numbers: 16242; UDI-DI: 00812559011730; 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.