Zeiss, Carl Inc: Medical Device Recall in 2018 - (Recall #: Z-2058-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.

Product Classification:

Class II

Date Initiated: May 8, 2018

Date Posted: June 20, 2018

Recall Number: Z-2058-2018

Event ID: 80115

Reason for Recall:

In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.

Status: Terminated

Product Quantity: 1070 units to US

Code Information:

Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes

Distribution Pattern:

USA (nationwide)

Voluntary or Mandated:

FDA Mandated