ZEISS Axio Observer 5 Microscope Recalled for Incorrect Device Identification Label
Zeiss is recalling ZEISS Axio Observer 5 microscopes due to an incorrect Unique Device Identification (UDI) label installed on some units. The labeling discrepancy affects device tracking and identification.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall with no reported illnesses, injuries, or safety hazards. The recall addresses a labeling and device identification discrepancy that poses no direct risk to device users or functionality.
Plain-English summary
Zeiss, Carl Inc is recalling certain ZEISS Axio Observer 5 microscopes (product material no. 431006-9901-000) due to an incorrect Unique Device Identification (UDI) label installed on affected units. The UDI label is used for device identification and regulatory tracking purposes.
The recall affects three microscopes total—one distributed in the United States (New York) and two distributed internationally. Affected units include those with serial number 3859001079.
Organizations that have received these microscopes should contact Zeiss, Carl Inc to report the labeling issue and obtain corrected labeling if needed.
The recalled product
- Product
- ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
- Manufacturer
- Zeiss, Carl Inc
- Hazard
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 (1)
- UDI-DI: 4064897000075 Serial Number: 3859001079
Distribution
Related recalls
Same manufacturer · Zeiss, Carl Inc
See all →- 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
- HighZeiss Laser Scanning Microscopes Recalled for Potential Laser Shutter Failure
FDA (Devices) · 2018-06-20
- 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 · incorrect labeling
See all →- High
- Moderate2022 Nissan Armada and Infiniti QX vehicles with incorrect GAWR label
NHTSA · 2026-07-15
- High
- HighMedtronic Recalls EOPA Arterial Cannula Models for Labeling Errors
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29