ZEISS Axio Observer 5 microscope, Product material no.… recallZ-1465-2022 · Zeiss, Carl Inc · initiated Jun 24, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zeiss, Carl Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
FDA root cause category: Process control
What the company is doing
On June 24, 2022, the firm notified their US customer of the recall via email. The customer was informed that a Zeiss service technician will contact them to arrange a date for performing a corrective action to eliminate the risk. The UDI label will be replaced.
Recall details
- Recall number
- Z-1465-2022
- Status
- Terminated
- Initiated by the company
- Jun 24, 2022
- Recalling firm
- Zeiss, Carl Inc
- Quantity
- 1 US; 2 OUS
- Product code
- MTX
- Distribution
- US Nationwide distribution in the state of NY.
Product description
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Code information (models, lots, serial numbers)
UDI-DI: 4064897000075 Serial Number: 3859001079
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Zeiss Axio Observer Axio Observer 5Carl Zeiss Microscopy GmbH · Microscope and microscope accessories, reproduction, assisted1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page