RegWardenFDA facility compliance records
Facility

Carl Zeiss Microscopy, GmbH

6 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 2 recalls; 2018: 2 recalls; 2019: 1 recalls; 2022: 1 recalls2’13’14’15’16’172’181’19’20’211’22’23’24’25’26
  • Recalls (6)

Devices registered here (1)

  • Microscope And Microscope Accessories, Reproduction, Assisted
    Product code MTX (opens in a new tab) · Class I · Obstetrics/Gynecology · 21 CFR 884.6190

Recalls & enforcement

  • Class IIITerminated2022-06-24
    An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
  • Class IITerminated2019-10-02
    When the user tilts the transmitted light arm of the microscope to the end of its axis range, laser safety can be bypassed and result in emission of class lIlb laser radiation. This issue arises when a ZEISS inverted stage stand (Axio Observer or Axio Vert) is used in as a compon…
  • Class IITerminated2018-05-29
    Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure of the users to harmful UV radiation.
  • Class IITerminated2018-05-08
    In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.
  • Class IITerminated2013-12-20
    Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.
  • Class IITerminated2013-05-28
    Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to Misaligned Full-Wave (Lambda) Plate.

Related

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

Cite this record

RegWarden. “Carl Zeiss Microscopy, GmbH (FEI 3012769735) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012769735-carl-zeiss-microscopy-gmbh/

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