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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
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