RegWardenFDA facility compliance records
Recall

Class II — Reichert, Inc.

Recalling firmREICHERT INC.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonThe head of the phoropter head could come loose and potentially detach due to a default in the assembly.
ProductPhoroptor VRx Digital Refraction System Model Numbers: 16241
Quantity122 units
DistributionDomestic: 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.
Initiated2025-02-28
Classified2025-03-31
Recall numberZ-1500-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Reichert, Inc. (Z-1500-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96266/

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