Zeiss Laser Scanning Microscopes Recalled for Potential Laser Shutter Failure
Zeiss is recalling specific laser scanning microscopes because the laser shutter may not close completely, allowing reflected beams to exceed Class I safety limits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (laser safety limit exceeded) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zeiss, Carl Inc is recalling certain Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. These instruments are used in cell biology research. The recall involves 1,070 units distributed nationwide in the United States.
The recall is being conducted because, in certain eyepiece configurations, the laser shutter may not close completely. This defect permits reflected beams that may be greater than the Class I limit, posing a potential safety risk to users.
Users of these microscopes should contact Zeiss, Carl Inc for further instructions on how to address the issue. The agency has classified this recall as Class II.
The recalled product
- Product
- 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.
- Manufacturer
- Zeiss, Carl Inc
- Hazard
- Affected units
- 1,070
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. Cell Observer SD
- Laser TIRF
- and DirectFRAP Laser Scanning Microscopes
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Zeiss, Carl Inc
See all →- LowZEISS Axio Observer 5 Microscope Recalled for Incorrect Device Identification Label
FDA (Devices) · 2022-08-03
- SevereZeiss Laser Scanning Microscope Component Recalled for Laser Safety Bypass
FDA (Devices) · 2020-04-15
- HighZeiss UV Disinfection Unit Recalled for Potential Radiation Exposure
FDA (Devices) · 2018-07-25
- ModerateZeiss Compensator Slider Lambda 6x20 Recalled for Misalignment
FDA (Devices) · 2014-01-29
- ModerateZeiss Microscope Polarizer D Component Recalled for Misaligned Plate
FDA (Devices) · 2013-07-24
Same hazard · laser exposure
See all →- HighFresh Roast ColorTrack instruments may allow excess infrared laser exposure
FDA (Devices) · 2026-06-17
- HighHeNe Laser System Allows Key Removal While Operating
FDA (Devices) · 2024-09-18
- HighHeNe Laser System Key Control Can Be Removed While Operating
FDA (Devices) · 2024-09-18
- HighRa Medical Systems Recalls DABRA Laser Due to Footswitch Defect
FDA (Devices) · 2020-12-23
- HighAerolase LightPod ERA Lasers Recalled for Missing Remote Interlock Connector
FDA (Devices) · 2020-01-15