Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Carl Zeiss AGLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Zeiss, Carl Inc with 6 device recalls. The most recent is a device recall dated Jun 24, 2022: ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 24, 2022 | ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000Class III · An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes. | Device recalls |
| Oct 2, 2019 | Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)Class II · When the user tilts the transmitted light arm of the microscope to the end of its axis range, laser safety can be bypass | Device recalls |
| May 29, 2018 | Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscopeClass II · Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate o | Device recalls |
| May 8, 2018 | Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. LaserClass II · In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be gr | Device recalls |
| Dec 20, 2013 | Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. AClass II · Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Micro | Device recalls |
| May 28, 2013 | Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.Class II · Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Ax | Device recalls |
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